Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

In the paper

“It compared cisplatin plus gemcitabine with cisplatin plus pemetrexed and demonstrated improved OS for patients with adenocarcinoma treated with cisplatin plus pemetrexed (whereas cisplatin plus gemcitabine was superior for patients with SCC).”

What the sources say

• Not checked yetcites Scagliotti et al68

In the paper

“OS, PFS, and response rate were not statistically significantly different. The study did meet its primary end point of OS without grade 3 to 4 toxicity with pemetrexed plus carboplatin.70”

What the sources say

• Not checked yetcites [70] Rodrigues-Pereira J, Kim JH, Magallanes M, et al. A randomized phase 3 trial comparing pemetrexed/carboplatin and docetaxel/carboplatin as first-line treatment for advanced, nonsquamous non-small cell lung cancer. J Thorac Oncol. 2011;6:1907–1914. doi: 10.1097/JTO.0b013e318226b5fa. [DOI] [PubMed] [Google Scholar]

In the paper

“The trial included participants with NSCC and SCC and compared nab-paclitaxel plus carboplatin with solvent-based paclitaxel plus carboplatin and found an improvement in the primary end point of response rate. There was no statistically significant difference in OS. Some adverse events occurred at a lower rate with the intervention.26”

What the sources say

• Not checked yetcites [26] Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non–small-cell lung cancer: Final results of a phase III trial. J Clin Oncol. 2012;30:2055–2062. doi: 10.1200/JCO.2011.39.5848. [DOI] [PubMed] [Google Scholar]

In the paper

“Carboplatin plus paclitaxel (ie, taxane plus carboplatin control) was used in both arms of a cetuximab trial that found no statistically significant difference in PFS; it lacked the power to determine an OS difference.71”

What the sources say

• Not checked yetcites [71] Lynch TJ, Patel T, Dreisbach L, et al. Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non–small-cell lung cancer: Results of the randomized multicenter phase III trial BMS099. J Clin Oncol. 2010;28:911–917. doi: 10.1200/JCO.2009.21.9618. [DOI] [PubMed] [Google Scholar]

In the paper

“Another trial compared two courses of cisplatin plus gemcitabine plus three courses of gemcitabine (arm one) versus five courses of cisplatin plus gemcitabine (arm two); the study did not demonstrate noninferiority in efficacy, and there was a higher rate of adverse events in arm two.39”

What the sources say

• Not checked yetcites [39] Novello S, Bruzzi P, Barone C, et al. Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone. Ann Oncol. 2007;18:903–908. doi: 10.1093/annonc/mdm061. [DOI] [PubMed] [Google Scholar]

In the paper

“Patients with severe comorbidity reported poorer HRQoL but not significantly greater deterioration of HRQoL.19”

What the sources say

• Not checked yetcites [19] Grønberg BH, Sundstrøm S, Kaasa S, et al. Influence of comorbidity on survival, toxicity and health-related quality of life in patients with advanced non-small-cell lung cancer receiving platinum-doublet chemotherapy. Eur J Cancer. 2010;46:2225–2234. doi: 10.1016/j.ejca.2010.04.009. [DOI] [PubMed] [Google Scholar]

In the paper

“In a study of pemetrexed plus carboplatin versus gemcitabine plus carboplatin, there was no statistically significant difference in efficacy; however, there were fewer hematologic adverse events with pemetrexed plus carboplatin.18”

What the sources say

• Not checked yetcites [18] Grønberg BH, Bremnes RM, Fløtten O, et al. Phase III study by the Norwegian lung cancer study group: Pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non–small-cell lung cancer. J Clin Oncol. 2009;27:3217–3224. doi: 10.1200/JCO.2008.20.9114. [DOI] [PubMed] [Google Scholar]

In the paper

“There were 51 trials in the first-line and maintenance settings, including seven trials for the treatment of patients with epidermal growth factor receptor (EGFR) mutations or increased EGFR expression.”

In the paper

“The only study showing positive results in a comparison between one of the listed cisplatin-based combinations and a new agent was for patients with EGFR-positive NSCLC (see Recommendation A4), in which afatinib was more efficacious than cisplatin plus pemetrexed.”

In the paper

“Patients with severe comorbidity had survival similar to that of other patients (6.9 v 8.1 months; P = .34) and a similar frequency of neutropenia (48% v 42%; P = .16) but experienced more neutropenic fevers (12% v 5%; P = .012) and deaths resulting from neutropenic infections (3% v 0%; P = .027).”

What the sources say

• Not checked yetcites [19] Grønberg BH, Sundstrøm S, Kaasa S, et al. Influence of comorbidity on survival, toxicity and health-related quality of life in patients with advanced non-small-cell lung cancer receiving platinum-doublet chemotherapy. Eur J Cancer. 2010;46:2225–2234. doi: 10.1016/j.ejca.2010.04.009. [DOI] [PubMed] [Google Scholar]

In the paper

“In one trial of four cycles of carboplatin plus paclitaxel versus five cycles of vinorelbine or gemcitabine, OS and PFS were statistically significantly longer with carboplatin plus paclitaxel, and adverse events occurred at a higher frequency53”

What the sources say

• Not checked yetcites [53] Quoix E, Zalcman G, Oster JP, et al. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011;378:1079–1088. doi: 10.1016/S0140-6736(11)60780-0. [DOI] [PubMed] [Google Scholar]

In the paper

“In a trial of cisplatin plus gemcitabine versus gemcitabine, OS and PFS were statistically significantly longer with the combination therapy.”

What the sources say

• Not checked yetcites [58] Morabito A, Gebbia V, Di Maio M, et al. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: The CAPPA-2 study. Lung Cancer. 2013;81:77–83. doi: 10.1016/j.lungcan.2013.04.008. [DOI] [PubMed] [Google Scholar]

In the paper

“One trial compared two nonplatinum regimens (paclitaxel plus gemcitabine v paclitaxel plus vinorelbine); paclitaxel plus vinorelbine did not improve efficacy and increased toxicity.75”

What the sources say

• Not checked yetcites [75] Kosmidis PA, Fountzilas G, Eleftheraki AG, et al. Paclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer: A phase III study of the Hellenic Cooperative Oncology Group (HeCOG) Ann Oncol. 2011;22:827–834. doi: 10.1093/annonc/mdq445. [DOI] [PubMed] [Google Scholar]

In the paper

“It compared pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab (arm one) versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab (arm two).37 PFS, but not OS, was improved using bevacizumab plus pemetrexed.”

What the sources say

• Not checked yetcites [37] Patel JD, Socinski MA, Garon EB, et al. PointBreak: A randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non–small-cell lung cancer. J Clin Oncol. 2013;31:4349–4357. doi: 10.1200/JCO.2012.47.9626. [DOI] [PMC free article] [PubMed] [Google Scholar]

In the paper

“Carboplatin plus paclitaxel was administered to the control arm in a trial of carboplatin plus oral S-1, a regimen used in Japan but not in the United States. The results of this trial showed noninferiority in OS with S-1.72”

What the sources say

• Not checked yetcites [72] Okamoto I, Yoshioka H, Morita S, et al. Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non–small-cell lung cancer: Results of a West Japan Oncology Group study. J Clin Oncol. 2010;28:5240–5246. doi: 10.1200/JCO.2010.31.0326. [DOI] [PubMed] [Google Scholar]

In the paper

“One trial that compared bevacizumab plus erlotinib versus bevacizumab plus placebo resulted in a 1.1-month longer PFS—the primary end point of the study—but there was no increase in OS, and adverse events were more frequent or of higher grade with the intervention.35”

What the sources say

• Not checked yetcites [35] Johnson BE, Kabbinavar F, Fehrenbacher L, et al. ATLAS: Randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non–small-cell lung cancer. J Clin Oncol. 2013;31:3926–3934. doi: 10.1200/JCO.2012.47.3983. [DOI] [PubMed] [Google Scholar]

In the paper

“In the present updated systematic review, four RCTs were identified that included bevacizumab33,35,37,76—three in the maintenance setting.”

What the sources say

• Not checked yetcites [33] Barlesi F, Scherpereel A, Rittmeyer A, et al. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non–small-cell lung cancer: AVAPERL (MO22089) J Clin Oncol. 2013;31:3004–3011. doi: 10.1200/JCO.2012.42.3749. [DOI] [PubMed] [Google Scholar]
• Not checked yetcites [35] Johnson BE, Kabbinavar F, Fehrenbacher L, et al. ATLAS: Randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non–small-cell lung cancer. J Clin Oncol. 2013;31:3926–3934. doi: 10.1200/JCO.2012.47.3983. [DOI] [PubMed] [Google Scholar]
• Not checked yetcites [37] Patel JD, Socinski MA, Garon EB, et al. PointBreak: A randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non–small-cell lung cancer. J Clin Oncol. 2013;31:4349–4357. doi: 10.1200/JCO.2012.47.9626. [DOI] [PMC free article] [PubMed] [Google Scholar]

In the paper

“The first trial,55 which included 205 participants, compared carboplatin plus pemetrexed with pemetrexed alone. In the results, OS and PFS were statistically significantly longer with the combination.”

What the sources say

• Not checked yetcites [55] Zukin M, Barrios CH, Pereira JR, et al. Randomized phase III trial of single-agent pemetrexed versus carboplatin and pemetrexed in patients with advanced non–small-cell lung cancer and Eastern Cooperative Oncology Group performance status of 2. J Clin Oncol. 2013;31:2849–2853. doi: 10.1200/JCO.2012.48.1911. [DOI] [PubMed] [Google Scholar]

In the paper

“Finally, no new trials included the combination of carboplatin plus irinotecan or carboplatin plus vinorelbine.”

In the paper

“One trial with 56 participants compared cisplatin plus gemcitabine with gemcitabine and found that OS and PFS were statistically significantly longer with the combination and QoL was also higher; however, the study was stopped early and had few participants.58”

What the sources say

• Not checked yetcites [58] Morabito A, Gebbia V, Di Maio M, et al. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: The CAPPA-2 study. Lung Cancer. 2013;81:77–83. doi: 10.1016/j.lungcan.2013.04.008. [DOI] [PubMed] [Google Scholar]

In the paper

“The updated systematic review included final OS results, which were not statistically significantly different (overall: 18.8 v 17.4 months; EGFR positive: 21.6 v 21.9 months).30”

What the sources say

• Not checked yetcites [30] Fukuoka M, Wu YL, Thongprasert S, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non–small-cell lung cancer in Asia (IPASS) J Clin Oncol. 2011;29:2866–2874. doi: 10.1200/JCO.2010.33.4235. [DOI] [PubMed] [Google Scholar] source

In the paper

“One study that compared pemetrexed and erlotinib did not find significant efficacy differences but did find a higher rate of hematologic adverse effects in the pemetrexed arm (neutropenia: P = .001; thrombocytopenia: P = .013; anemia: P = .001).93”

What the sources say

• Not checked yetcites [93] Karampeazis A, Voutsina A, Souglakos J, et al. Pemetrexed versus erlotinib in pretreated patients with advanced non-small cell lung cancer: A Hellenic Oncology Research Group (HORG) randomized phase 3 study. Cancer. 2013;119:2754–2764. doi: 10.1002/cncr.28132. [DOI] [PubMed] [Google Scholar]

In the paper

“This benefit was retained with doublet therapy in the subgroup with PS 2 and in those age > 80 years, which each constituted approximately one fourth of the study population.”

What the sources say

• Not checked yetcites [53] Quoix E, Zalcman G, Oster JP, et al. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011;378:1079–1088. doi: 10.1016/S0140-6736(11)60780-0. [DOI] [PubMed] [Google Scholar]

In the paper

“In one trial,47 PFS, but not OS, was higher with chemotherapy.”

What the sources say

• Not checked yetcites [47] Lee DH, Park K, Kim JH, et al. Randomized phase III trial of gefitinib versus docetaxel in non-small cell lung cancer patients who have previously received platinum-based chemotherapy. Clin Cancer Res. 2010;16:1307–1314. doi: 10.1158/1078-0432.CCR-09-1903. [DOI] [PubMed] [Google Scholar]

In the paper

“It compared four cycles of carboplatin plus paclitaxel versus monotherapy; OS favored the doublet for an elderly population. Median OS was superior for doublet chemotherapy versus monotherapy (10.3 v 6.2 months; HR, 0.64; P < .001).”

What the sources say

• Not checked yetcites [53] Quoix E, Zalcman G, Oster JP, et al. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011;378:1079–1088. doi: 10.1016/S0140-6736(11)60780-0. [DOI] [PubMed] [Google Scholar]

In the paper

“PFS was 0.5 months longer.”

What the sources say

• Not checked yetcites [41] Garassino MC, Martelli O, Broggini M, et al. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): A randomised controlled trial. Lancet Oncol. 2013;14:981–988. doi: 10.1016/S1470-2045(13)70310-3. [DOI] [PubMed] [Google Scholar]

In the paper

“Treatment-related serious adverse events more frequent with chemotherapy, although rash was more common with erlotinib.46”

What the sources say

• Not checked yetcites [46] Ciuleanu T, Stelmakh L, Cicenas S, et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): A randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012;13:300–308. doi: 10.1016/S1470-2045(11)70385-0. [DOI] [PubMed] [Google Scholar]

In the paper

“Hematologic adverse events were more frequent with ramucirumab plus docetaxel, as were other adverse events, such as diarrhea, dyspnea, and fatigue.57”

What the sources say

• Not checked yetcites [57] Garon EB, Ciuleanu TE, Arrieta O. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): A multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384:665–673. doi: 10.1016/S0140-6736(14)60845-X. [DOI] [PubMed] [Google Scholar] source

In the paper

“Serious adverse events were more frequent with chemotherapy, although treatment-related deaths were more frequent among patients treated with gefitinib.47”

What the sources say

• Not checked yetcites [47] Lee DH, Park K, Kim JH, et al. Randomized phase III trial of gefitinib versus docetaxel in non-small cell lung cancer patients who have previously received platinum-based chemotherapy. Clin Cancer Res. 2010;16:1307–1314. doi: 10.1158/1078-0432.CCR-09-1903. [DOI] [PubMed] [Google Scholar]

In the paper

“A similar protocol amendment occurred in the TITAN trial, in which 35% to 38% of participants had SCC; however, participants were not stratified according to histology, and analyses by histology were not preplanned.46”

What the sources say

• Not checked yetcites [46] Ciuleanu T, Stelmakh L, Cicenas S, et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): A randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012;13:300–308. doi: 10.1016/S1470-2045(11)70385-0. [DOI] [PubMed] [Google Scholar]

In the paper

“No significant differences in OS were found for participants with SCC, but TTP was longer with erlotinib (both findings were identified in exploratory analyses by histology; OS: P = .006).93”

What the sources say

• Not checked yetcites [93] Karampeazis A, Voutsina A, Souglakos J, et al. Pemetrexed versus erlotinib in pretreated patients with advanced non-small cell lung cancer: A Hellenic Oncology Research Group (HORG) randomized phase 3 study. Cancer. 2013;119:2754–2764. doi: 10.1002/cncr.28132. [DOI] [PubMed] [Google Scholar]

In the paper

“One trial tested a new vascular endothelial growth factor inhibitor for NSCLC, ramucirumab (plus docetaxel); the intervention arm experienced longer PFS (by 1.5 months) and OS (by 1.4 months), both statistically significant.”

What the sources say

• Not checked yetcites [57] Garon EB, Ciuleanu TE, Arrieta O. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): A multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384:665–673. doi: 10.1016/S0140-6736(14)60845-X. [DOI] [PubMed] [Google Scholar] source

In the paper

“The objective response rate was 72% (95% CI, 58 to 84), and there were three complete responses and 33 partial responses.”

What the sources say

• Not checked yetcites [78] Shaw AT, Ou SH, Bang YJ, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014;371:1963–1971. doi: 10.1056/NEJMoa1406766. [DOI] [PMC free article] [PubMed] [Google Scholar] source

In the paper

“In the last trial,49 PFS, but not OS, was longer with gefitinib versus pemetrexed, and serious adverse events more frequent with gefitinib.”

What the sources say

• Not checked yetcites [49] Sun JM, Lee KH, Kim SW, et al. Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01): An open-label, phase 3 trial. Cancer. 2012;118:6234–6242. doi: 10.1002/cncr.27630. [DOI] [PubMed] [Google Scholar]

In the paper

“There was no efficacy advantage in another trial23; overall adverse events more frequent with chemotherapy.23”

What the sources say

• Not checked yetcites [23] Maruyama R, Nishiwaki Y, Tamura T, et al. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non–small-cell lung cancer. J Clin Oncol. 2008;26:4244–4252. doi: 10.1200/JCO.2007.15.0185. [DOI] [PubMed] [Google Scholar]

In the paper

“Although PFS was statistically significantly longer at 0.7 months with the combination, the OS improvement (ie, 2.57 months longer) did not reach statistical significance.”

What the sources say

• Not checked yetcites [67] Pallis AG, Agelaki S, Agelidou A, et al. A randomized phase III study of the docetaxel/carboplatin combination versus docetaxel single-agent as second line treatment for patients with advanced/metastatic non-small cell lung cancer. BMC Cancer. 2010;10:633. doi: 10.1186/1471-2407-10-633. [DOI] [PMC free article] [PubMed] [Google Scholar]

In the paper

“Expected chemotherapy adverse effects were more common in the docetaxel arm, and rash (but not diarrhea) occurred more frequently in the erlotinib arm.41”

What the sources say

• Not checked yetcites [41] Garassino MC, Martelli O, Broggini M, et al. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): A randomised controlled trial. Lancet Oncol. 2013;14:981–988. doi: 10.1016/S1470-2045(13)70310-3. [DOI] [PubMed] [Google Scholar]

In the paper

“Some hematologic adverse events were more frequent with first-line chemotherapy; as expected, rash occurred more often with first-line erlotinib.94”

What the sources say

• Not checked yetcites [94] Gridelli C, Ciardiello F, Gallo C, et al. First-line erlotinib followed by second-line cisplatin–gemcitabine chemotherapy in advanced non–small-cell lung cancer: The TORCH randomized trial. J Clin Oncol. 2012;30:3002–3011. doi: 10.1200/JCO.2011.41.2056. [DOI] [PubMed] [Google Scholar]

In the paper

“Efficacy outcomes were lower with first-line erlotinib, but the differences were not statistically significant.”

What the sources say

• Not checked yetcites [94] Gridelli C, Ciardiello F, Gallo C, et al. First-line erlotinib followed by second-line cisplatin–gemcitabine chemotherapy in advanced non–small-cell lung cancer: The TORCH randomized trial. J Clin Oncol. 2012;30:3002–3011. doi: 10.1200/JCO.2011.41.2056. [DOI] [PubMed] [Google Scholar]

In the paper

“Other studies found in the updated systematic review did not result in evidence supporting other changes in the recommendation. These studies investigated thalidomide,38 bevacizumab plus erlotinib,35 gemcitabine,39 bevacizumab plus pemetrexed,33,37 bevacizumab alone,37 and gefitinib.34,36”

What the sources say

• Not checked yetcites [38] Lee SM, Rudd R, Woll PJ, et al. Randomized double-blind placebo-controlled trial of thalidomide in combination with gemcitabine and Carboplatin in advanced non–small-cell lung cancer. J Clin Oncol. 2009;27:5248–5254. doi: 10.1200/JCO.2009.21.9733. [DOI] [PubMed] [Google Scholar]
• Not checked yetcites [35] Johnson BE, Kabbinavar F, Fehrenbacher L, et al. ATLAS: Randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non–small-cell lung cancer. J Clin Oncol. 2013;31:3926–3934. doi: 10.1200/JCO.2012.47.3983. [DOI] [PubMed] [Google Scholar]
• Not checked yetcites [39] Novello S, Bruzzi P, Barone C, et al. Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone. Ann Oncol. 2007;18:903–908. doi: 10.1093/annonc/mdm061. [DOI] [PubMed] [Google Scholar]

In the paper

“In the largest trial of concurrent palliative care plus oncology care versus oncology care alone, patients treated by their oncologists alone had less prognostic awareness that they could not be cured, received more intravenous chemotherapy in the last 60 days of life, used hospice less often and for shorter periods, and died 2.7 months sooner than those who used palliative care.111”

What the sources say

• Not checked yetcites [111] Roeland E, Loprinzi C, Moynihan TJ, et al. In chemotherapy for lung cancer, sometimes less is more. J Natl Compr Canc Netw. 2013;11:232–235. doi: 10.6004/jnccn.2013.0034. [DOI] [PubMed] [Google Scholar]

In the paper

“No studies were found to recommend a change from the previous recommendation.”

In the paper

“The evidence does not support the selection of a specific second-line chemotherapy drug or combination based on age alone.”

In the paper

“However, final results of OS have not been reported for most studies; therefore, the outcomes of those patients who crossed over to chemotherapy have not been yet analyzed.11,13,20,29,94”

What the sources say

• Not checked yetcites [11] Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31:3327–3334. doi: 10.1200/JCO.2012.44.2806. [DOI] [PubMed] [Google Scholar] source
• Not checked yetcites [13] Zhou C, Wu YL, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): A multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011;12:735–742. doi: 10.1016/S1470-2045(11)70184-X. [DOI] [PubMed] [Google Scholar] source
• Not checked yetcites [20] Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–2388. doi: 10.1056/NEJMoa0909530. [DOI] [PubMed] [Google Scholar] source

In the paper

“Neither study reported the survival of patients who did or did not experience an initial response to gefitinib.20,21”

What the sources say

• Not checked yetcites [20] Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–2388. doi: 10.1056/NEJMoa0909530. [DOI] [PubMed] [Google Scholar] source
• Not checked yetcites [21] Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002) Ann Oncol. 2013;24:54–59. doi: 10.1093/annonc/mds214. [DOI] [PubMed] [Google Scholar] source

In the paper

“These studies have also reported better QoL, less depression and anxiety, and less caregiver distress with palliative care.”

In the paper

“There are not enough data on patients with large-cell neuroendocrine carcinoma or enough mature data on ROS1 and crizotinib or on second-line treatment for patients who received first-line treatment with an EGFR TKI and experienced disease progression or for those who received an EGFR TKI and had an initial response.”

In the paper

“An environmental scan of related literature published since 2009 found that patients with NSCLC continue to grapple with complex medical, psychological, and social issues.”

In the paper

“There are not yet sufficient objective tools available to clinicians to determine which patients would benefit from and tolerate combined therapy in comparison with single-agent chemotherapy.”

In the paper

“In addition, there are not enough mature data on adding pemetrexed to bevacizumab plus carboplatin; there has been only one phase III trial.153”

What the sources say

• Not checked yetcites [153] Patel JD, Hensing TA, Rademaker A, et al. Phase II study of pemetrexed and carboplatin plus bevacizumab with maintenance pemetrexed and bevacizumab as first-line therapy for nonsquamous non–small-cell lung cancer. J Clin Oncol. 2009;27:3284–3289. doi: 10.1200/JCO.2008.20.8181. [DOI] [PubMed] [Google Scholar]

In the paper

“Some factors varied between studies, lowering the comparability of the results.”

In the paper

“This update includes 73 phase III randomized controlled trials (RCTs) on systemic therapy.”

In the paper

“Articles were excluded from the systematic review if they were: (1) meeting abstracts not subsequently published in peer-reviewed journals (with one exception made for 2014 ASCO abstract presenting only phase III data on agent recently approved by US Food and Drug Administration [FDA]6); (2) editorials, commentaries, letters, news articles, case reports, or narrative reviews; or (3) published in a”

In the paper

“however, the trial had low accrual and was stopped early58”

What the sources say

• Not checked yetcites [58] Morabito A, Gebbia V, Di Maio M, et al. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: The CAPPA-2 study. Lung Cancer. 2013;81:77–83. doi: 10.1016/j.lungcan.2013.04.008. [DOI] [PubMed] [Google Scholar]

In the paper

“In accordance with these procedures, the majority of the members of the Update Committee did not disclose any such relationships.”

In the paper

“The guideline recommendations were crafted, in part, using the Guidelines Into Decision Support (GLIDES) methodology and accompanying BRIDGE-Wiz software (http://gem.med.yale.edu/BRIDGE-Wiz).”

In the paper

“Study quality was formally assessed for the RCTs directly relevant to current recommendations”

In the paper

“The Update Committee was assembled in accordance with the ASCO Conflicts of Interest Management Procedures for Clinical Practice Guidelines (summarized at http://www.asco.org/rwc).”

In the paper

“Because there is no cure for patients with stage IV NSCLC, early concomitant palliative care assistance has improved the survival and well being of patients and is therefore recommended”

What the sources say

• Not checked yetcites [5] Smith TJ, Temin S, Alesi ER, et al. American Society of Clinical Oncology provisional clinical opinion: The integration of palliative care into standard oncology care. J Clin Oncol. 2012;30:880–887. doi: 10.1200/JCO.2011.38.5161. [DOI] [PubMed] [Google Scholar]

In the paper

“In some selected cases where evidence was lacking but there was a high level of agreement among the Update Committee, informal consensus was used (as noted with Recommendations).”

In the paper

“Articles were selected for inclusion in the systematic review of the evidence based on the following criteria: (1) population of patients with stage IV NSCLC (many trials also included patients with stage IIIB NSCLC), and (2) fully published presentations of English-language reports of phase III RCTs.”

In the paper

“The PubMed database was searched for evidence reporting on outcomes of interest, published from January 2007 to February 2014 for non–switch maintenance questions and from June 2009 to February 2014 for switch maintenance questions.”

In the paper

“Design aspects related to the individual study quality were assessed by one reviewer, with factors such as blinding, allocation concealment, placebo control, intention to treat, and funding sources generally indicating an intermediate to high potential risk of bias for most of the identified evidence.”

In the paper

“the study was closed prematurely.52”

What the sources say

• Not checked yetcites [52] Georgoulias V, Androulakis N, Kotsakis A, et al. Docetaxel versus docetaxel plus gemcitabine as front-line treatment of patients with advanced non-small cell lung cancer: A randomized, multicenter phase III trial. Lung Cancer. 2008;59:57–63. doi: 10.1016/j.lungcan.2007.07.021. [DOI] [PubMed] [Google Scholar]

In the paper

“These agents offer equal or superior efficacy and toxicity profiles compared with standard cytotoxic chemotherapy.”

In the paper

“Patients with negative or unknown EGFR/ALK status with SCC histology and PS 2 may benefit from treatment with either combination or single-agent chemotherapy.”

In the paper

“The data regarding adding bevacizumab to carboplatin plus pemetrexed are not yet mature; therefore, there are insufficient data on which to base a recommendation.”

In the paper

“However, these uncommon tumors are important to identify, because they are treatable with FDA-approved oral agents (crizotinib and ceritinib).”

In the paper

“Combination treatment can improve outcomes for patients with negative or unknown EGFR/ALK status with NSCC histology and PS 0 to 2 who may also receive treatment with either combination or single-agent chemotherapy or palliative care concurrently or alone.”

In the paper

“however, the study was stopped early and had few participants.58”

What the sources say

• Not checked yetcites [58] Morabito A, Gebbia V, Di Maio M, et al. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: The CAPPA-2 study. Lung Cancer. 2013;81:77–83. doi: 10.1016/j.lungcan.2013.04.008. [DOI] [PubMed] [Google Scholar]

In the paper

“The individual patient data meta-analysis by Di Maio et al95 of single versus doublet therapy in the second-line setting found that “doublet chemotherapy as second-line treatment of advanced NSCLC significantly increases response rate and progression-free survival, but is more toxic and does not improve overall survival compared with single-agent.”95(p1836)”

What the sources say

• Not checked yetcites Di Maio et al95

In the paper

“Single-agent therapy is appropriate for patients with SCC in the second-line setting.”

In the paper

“Median time to response was 3.3 months; median duration of response had not been reached at the time of publication.”

What the sources say

• Not checked yetcites [98] Rizvi NA, Mazières J, Planchard D, et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): A phase 2, single-arm trial. Lancet Oncol. 2015;16:257–265. doi: 10.1016/S1470-2045(15)70054-9. [DOI] [PMC free article] [PubMed] [Google Scholar] source

In the paper

“There is no definite evidence that combination therapy is superior, but it may be more toxic.”

In the paper

“Nonetheless, there is no absolute preference for chemotherapy versus targeted therapy.”

In the paper

“Adverse effects included dyspnea, fatigue, pneumonitis, diarrhea, musculoskeletal pain, and severe immune-mediated adverse effects98,99; 59% of patients experienced serious adverse events.100”

What the sources say

• Not checked yetcites [98] Rizvi NA, Mazières J, Planchard D, et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): A phase 2, single-arm trial. Lancet Oncol. 2015;16:257–265. doi: 10.1016/S1470-2045(15)70054-9. [DOI] [PMC free article] [PubMed] [Google Scholar] source
• Not checked yetcites [99]
• Not checked yetcites [100]

In the paper

“These patients are unlikely to harbor EGFR/ALK gene mutations and may benefit from chemotherapy rather than targeted therapy with an EGFR TKI.”

In the paper

“In the IPASS trial comparing gefitinib with carboplatin plus paclitaxel, in the subgroup of patients with unknown EGFR mutation status, there were statistically significantly longer PFS and higher response rates.61”

What the sources say

• Not checked yetcites [61] Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361:947–957. doi: 10.1056/NEJMoa0810699. [DOI] [PubMed] [Google Scholar] source

In the paper

“Patients with nonsquamous histology who have not received pemetrexed therapy in the first-line setting may benefit from receiving pemetrexed in the second-line setting.”

In the paper

“In the absence of EGFR/ALK mutations, chemotherapy may be a preferable approach.”

In the paper

“In a prespecified analysis, participants with a complete or partial response to a first-line EGFR TKI whose tumors also had known EGFR mutation test results (58 [88%] of 66), the HR for PFS was significant (0.23), but the HR for OS was not (0.90) in the afatinib arm.”

What the sources say

• Not checked yetcites [15] Miller VA, Hirsh V, Cadranel J, et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): A phase 2b/3 randomised trial. Lancet Oncol. 2012;13:528–538. doi: 10.1016/S1470-2045(12)70087-6. [DOI] [PubMed] [Google Scholar] source

In the paper

“Similarly, another phase III study of gefitinib versus carboplatin plus paclitaxel in patients with EGFR-sensitizing mutations also found an improvement in PFS but not OS, again presumably secondarily to crossover to chemotherapy in the gefitinib arm.”

What the sources say

• Not checked yetcites [20] Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–2388. doi: 10.1056/NEJMoa0909530. [DOI] [PubMed] [Google Scholar] source
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In the paper

“Toxicities (and durability) seem similar to those of crizotinib, including a low risk for serious pneumonitis; long-term outcomes are still under study.”

In the paper

“In the afatinib trial, response rates in both arms were lower than in studies with chemotherapy; however, given the longer PFS, afatinib after gefitinib or erlotinib in patients with EGFR-sensitizing mutations who experienced an initial response may be an option.”

In the paper

“The FDA-approved label for patients who receive ceritinib who have previously received crizotinib states that “continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.””

In the paper

“As stated in Recommendation A8, age alone is not a contraindication to chemotherapy for NSCLC.”

In the paper

“In a report by Shaw et al,42 80 of 122 of previously treated patients had received crizotinib, and the response rate with ceritinib was 56% (95% CI, 45 to 67).”

What the sources say

• Not checked yetcites [42] Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014;370:1189–1197. doi: 10.1056/NEJMoa1311107. [DOI] [PMC free article] [PubMed] [Google Scholar]

In the paper

“In 2012, ASCO reviewed the evidence from an RCT showing an increase in median OS for patients receiving palliative care services concurrently with disease-modifying therapy. The participants in that study had stage IV NSCLC.”

In the paper

“Grade 3 to 4 adverse effects in all patients included increases in ALT, AST, and glucose, as well as diarrhea.”

What the sources say

• Not checked yetcites [43] Kim DW, Mehra R, Tan DSW. Ceritinib in advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): Results of the ASCEND-1 trial. J Clin Oncol. 2014;32(suppl 5s):506s. abstr 8003. [Google Scholar]

In the paper

“The study found no improvement in the primary end point of OS between patients randomly assigned to afatinib and those randomly assigned to placebo, although PFS was longer in the afatinib group (3.3 v 1.1 months; HR, 0.38; 95% CI, 0.31 to 0.48; P < .001).”

What the sources say

• Not checked yetcites [15] Miller VA, Hirsh V, Cadranel J, et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): A phase 2b/3 randomised trial. Lancet Oncol. 2012;13:528–538. doi: 10.1016/S1470-2045(12)70087-6. [DOI] [PubMed] [Google Scholar] source

In the paper

“Grade 3 to 4 adverse effects included increased ALT and increased AST levels, diarrhea, and increased lipase levels. There were four cases of interstitial lung disease.”

What the sources say

• Not checked yetcites [42] Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014;370:1189–1197. doi: 10.1056/NEJMoa1311107. [DOI] [PMC free article] [PubMed] [Google Scholar]

In the paper

“PFS was 6.9 months (95% CI, 5.39 to 8.41) for those pretreated with crizotinib, and the overall response rate was 54.6 (95% CI, 46.6 to 62.4).”

What the sources say

• Not checked yetcites [43] Kim DW, Mehra R, Tan DSW. Ceritinib in advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): Results of the ASCEND-1 trial. J Clin Oncol. 2014;32(suppl 5s):506s. abstr 8003. [Google Scholar]

In the paper

“The BMS099 trial of cetuximab in addition to taxane plus carboplatin versus taxane plus carboplatin resulted in a shorter PFS with cetuximab and some adverse effects.71”

What the sources say

• Not checked yetcites [71] Lynch TJ, Patel T, Dreisbach L, et al. Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non–small-cell lung cancer: Results of the randomized multicenter phase III trial BMS099. J Clin Oncol. 2010;28:911–917. doi: 10.1200/JCO.2009.21.9618. [DOI] [PubMed] [Google Scholar]

In the paper

“This confirmed the evidence from multiple randomized trials that included patients with cancer who showed an improvement in symptoms, including less anxiety and depression, higher satisfaction, less aggressive end-of-life care, and less caregiver distress.108”

What the sources say

• Not checked yetcites [108] Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363:733–742. doi: 10.1056/NEJMoa1000678. [DOI] [PubMed] [Google Scholar]

In the paper

““In medical consultations, patients experience a double-need: to know and understand and to feel known and understood.”121(p3274),127”

What the sources say

• Not checked yetcites 121(p3274)
• Not checked yetcites [127] McGuire L. Ourselves and patients who are dying. Pharos. 1990;53:6–8. [PubMed] [Google Scholar]

In the paper

“Socioeconomic status is likely an independent prognostic factor for lung cancer survival.134”

What the sources say

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In the paper

“Black men continue to have higher incidence rates of lung cancer than white non-Hispanic men.141”

What the sources say

• Not checked yetcites [141] Howlader N, Noone AM, Krapcho M, et al. SEER cancer statistics review, 1975-2011. http://seer.cancer.gov/csr/1975_2011/

In the paper

“Socioeconomic factors, insurance coverage, and residential segregation also play a role in lung cancer disparities.128,136–138”

What the sources say

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In the paper

“Race is associated with lack of any treatment, lack of timely treatment, and lack of appropriate treatment.129,132,142”

What the sources say

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In the paper

“Each of those listed here is reported with a frequency > 50% in patients age ≥ 65 years, with the prevalence of hypertension, hyperlipidemia, and ischemic heart disease being significantly greater in the older age group.”

What the sources say

• Not checked yetcites [148]

In the paper

“Because of a misunderstanding about prognosis, one third of patients (46 of 145) reported that their cancer was curable at baseline, and a majority of patients (86 of 124) endorsed getting rid of all of the cancer as a goal of therapy.125”

What the sources say

• Not checked yetcites [125] Temel JS, Greer JA, Admane S, et al. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non–small-cell lung cancer: Results of a randomized study of early palliative care. J Clin Oncol. 2011;29:2319–2326. doi: 10.1200/JCO.2010.32.4459. [DOI] [PubMed] [Google Scholar]

In the paper

“However, as stated in the 2009 guideline,113 equal access to care can provide similar outcomes.”

What the sources say

• Not checked yetcites [113]

In the paper

“Elderly and female patients also receive disparate treatment.132”

What the sources say

• Not checked yetcites [132] Hardy D, Liu CC, Xia R, et al. Racial disparities and treatment trends in a large cohort of elderly black and white patients with nonsmall cell lung cancer. Cancer. 2009;115:2199–2211. doi: 10.1002/cncr.24248. [DOI] [PubMed] [Google Scholar]

In the paper

“Patients with NSCLC often have MCCs; the five most commonly encountered chronic conditions in patients with lung cancer irrespective of age include hypertension, chronic obstructive pulmonary disease, hyperlipidemia, ischemic heart disease, and anemia148”

What the sources say

• Not checked yetcites [148]

In the paper

“There are various validated tools to study comorbidity, particularly in the geriatric literature; these include the Charlson comorbidity index, the Cumulative Illness Rating Scale, the Older Americans Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire, and the Adult Comorbidity Evaluation–27 Index (latter index has been validated irrespective of age).149–152”

What the sources say

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In the paper

“A stigma is connected with lung cancer because of the association with smoking; this stigma increases depression and decreases QoL.124”

What the sources say

• Not checked yetcites [124] Brown Johnson CG, Brodsky JL, Cataldo JK. Lung cancer stigma, anxiety, depression, and quality of life. J Psychosoc Oncol. 2014;32:59–73. doi: 10.1080/07347332.2013.855963. [DOI] [PMC free article] [PubMed] [Google Scholar]

In the paper

“Patients with cancer who are members of racial or ethnic minorities may disproportionately experience comorbidities, experience more substantial obstacles to receiving care, be more likely lack insurance, and face a greater risk of receiving poor-quality care than other Americans.140,141,146,147”

What the sources say

• Not checked yetcites [140] American Cancer Society. Cancer Facts & Figures for African Americans 2013-2014. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036921.pdf. source
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• Not checked yetcites [146] Mead H, Cartwright-Smith L, Jones K, et al. Health Care: A Chartbook. New York, NY: Commonwealth Fund; 2008. Racial and Ethnic Disparities in U.S. [Google Scholar] source

In the paper

“Patients with NSCLC often have MCCs; the five most commonly encountered chronic conditions in patients with lung cancer irrespective of age include hypertension, chronic obstructive pulmonary disease, hyperlipidemia, ischemic heart disease, and anemia148”

What the sources say

• Not checked yetcites [148]

In the paper

“Death rates in lung cancer are higher for black men than white men,141 as well as for American Indians and Alaska natives.143”

What the sources say

• Not checked yetcites [141] Howlader N, Noone AM, Krapcho M, et al. SEER cancer statistics review, 1975-2011. http://seer.cancer.gov/csr/1975_2011/
• Not checked yetcites [143] Smith CB, Bonomi M, Packer S, et al. Disparities in lung cancer stage, treatment and survival among American Indians and Alaskan Natives. Lung Cancer. 2011;72:160–164. doi: 10.1016/j.lungcan.2010.08.015. [DOI] [PubMed] [Google Scholar]

In the paper

“For example, in the study of early palliative care for patients with NSCLC discussed in the ASCO provisional clinical opinion, 14% of 151 patients had major depressive syndrome, which significantly predicted worse survival.123”

What the sources say

• Not checked yetcites [123] Pirl WF, Greer JA, Traeger L, et al. Depression and survival in metastatic non-small-cell lung cancer: Effects of early palliative care. J Clin Oncol. 2012;30:1310–1315. doi: 10.1200/JCO.2011.38.3166. [DOI] [PMC free article] [PubMed] [Google Scholar]