Use of nivolumab in elderly patients with advanced squamous non-small-cell lung cancer: results from the Italian cohort of an expanded access programme
Abstract
Aim This analysis evaluated the efficacy and safety of nivolumab, an immune checkpoint inhibitor, in elderly patients with stage IIIB or IV squamous non-small-cell lung cancer (NSCLC) enrolled in the expanded access programme (EAP) in Italy.Methods Nivolumab was available on physician request. Safety data included adverse events (AEs). Efficacy data included investigator-assessed tumour response, progression date and survival information. Results were analysed for patients aged <65, 65-<75 and ≥75 years and for the overall population.Results A total of 371 patients with squamous NSCLC were enrolled at 96 centres between April 2015 and September 2015; 34% (n = 126), 47% (n = 175) and 19% (n = 70) were aged <65, 65-<75 and ≥75 years, respectively. Efficacy was similar among patients aged <65, 65-<75 and ≥75 years and the overall population (objective response rates: 18%, 18%, 19% and 18%, respectively; disease control rates: 49%, 47%, 43% and 47%, respectively). Median overall survival was reduced in patients aged ≥75 years (5.8 months) versus patients aged <65; years (8.6 months), patients aged 65-<75 years (8.0 months) and the overall population (7.9 months). The incidence of grade 3-4 treatment-related AEs was low in patients aged 65, 65-<75 and ≥75 years and the overall population (3%, 9%, 3%, 6%, respectively). Discontinuation rates due to treatment-related AEs were low irrespective of age (4-5%).Conclusions These EAP results suggest that elderly patients with advanced squamous NSCLC benefit from nivolumab, with tolerability similar to that in the overall population.
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There is evidence about the efficacy of anti PD-1/PD-L1 MoAbs in older patients with non-small cell lung cancer compared with chemotherapy.
“Moreover, there is evidence about the efficacy of anti PD-1/PD-L1 MoAbs in older patients with non-small cell lung cancer (NSCLC) compared with chemotherapy.”
From Immunosenescence and Its Hallmarks: How to Oppose Aging Strategically? A Review of Potential Options for Therapeutic Intervention (2019) · cites this paper as [173]
The benefit of immunotherapy in terms of response is stackable between younger and older patients.
“The benefit of immunotherapy in terms of response is stackable between younger and older patients (173).”
From Immunosenescence and Its Hallmarks: How to Oppose Aging Strategically? A Review of Potential Options for Therapeutic Intervention (2019) · cites this paper as [173]
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Impact of PD1 and PDL1 immunotherapy on non-small cell lung cancer outcomes: a systematic review
Kanabar, S. S., Tiwari, A., Soran, V., Balendran, P., Price, M. J., & Turner, A. M. (2022) · Thorax · doi:10.1136/thoraxjnl-2020-215614 · Cited by 16 · see citing works
Geriatric Radiation Oncology: What We Know and What Can We Do Better?
Roeder, F., Jensen, A. D., Lindel, K., Mattke, M., Wolf, F., & Gerum, S. (2023) · Clinical Interventions in Aging · doi:10.2147/cia.s365495 · Cited by 16 · see citing works
Bassanelli, M., Ricciuti, B., Giannarelli, D., Cecere, F. L., Roberto, M., Giacinti, S., Barucca, V., Santarelli, M., Ruggeri, E. M., Marchetti, P., et al. (2021) · Tumori Journal · doi:10.1177/03008916211004733 · Cited by 16 · see citing works
Real World Experience of Nivolumab in Non-Small Cell Lung Cancer in Korea
Lim, S. M., Kim, S.-W., Cho, B. C., Kang, J., Ahn, M., Kim, D., Kim, Y., Lee, J. S., Lee, J.-S., Lee, S. Y., et al. (2020) · Cancer Research and Treatment · doi:10.4143/crt.2020.245 · Cited by 15 · see citing works
Kondo, T., Okamoto, I., Sato, H., Koyama, N., Fushimi, C., Okada, T., Masubuchi, T., Miura, K., Matsuki, T., Yamashita, T., et al. (2020) · Asia-Pacific Journal of Clinical Oncology · doi:10.1111/ajco.13374 · Cited by 15 · see citing works
Kurokawa, K., Mitsuishi, Y., Shimada, N., Kawakami, Y., Miura, K., Miyawaki, T., Asao, T., Ko, R., Shukuya, T., Shibayama, R., et al. (2022) · BMC Cancer · doi:10.1186/s12885-022-10133-1 · Cited by 14 · see citing works
Zhou, H., Zheng, Z., Fan, C., & Zhou, Z. (2025) · Seminars in Cancer Biology · doi:10.1016/j.semcancer.2025.01.001 · Cited by 15 · see citing works
Couderc, A., Tomasini, P., Nouguerède, E., Rey, D., Corréard, F., Montégut, C., Thomas, P. A., Villani, P., Barlési, F., & Greillier, L. (2020) · Clinical Lung Cancer · doi:10.1016/j.cllc.2020.06.004 · Cited by 15 · see citing works
Masuda, T., Fujitaka, K., Suzuki, T., Hamai, K., Matsumoto, N., Matsumura, M., Isoyama, S., Ueno, S., Mito, M., Yamaguchi, K., et al. (2022) · Thoracic Cancer · doi:10.1111/1759-7714.14428 · Cited by 13 · see citing works
“6 months).(7) However, no prospective study on the efficacy and safety of pembrolizumab in elderly patients with NSCLC and a PD-L1 TPS of ≥50% has been conducted.”
BackgroundImmunosenescence and immunotherapy in older NSCLC patients
Zhang, J., Zhao, L., Li, H., Jia, Y., & Kong, F. (2024) · Journal of Cancer Research and Therapeutics · doi:10.4103/jcrt.jcrt_1523_23 · Cited by 12 · see citing works
Joris, S., Pieters, T., Sibille, A., Bustin, F., Jacqmin, L., Kalantari, H. R., Surmont, V. F. M., Goeminne, J., Clinckart, F., Pat, K., et al. (2019) · Journal of Geriatric Oncology · doi:10.1016/j.jgo.2019.09.011 · Cited by 12 · see citing works
Do Elderly Lung Cancer Patients Aged ≥75 Years Benefit from Immune Checkpoint Inhibitors?
Takigawa, N., Ochi, N., Nakagawa, N., Nagasaki, Y., Taoka, M., Ichiyama, N., Mimura, A., Nakanishi, H., Kohara, H., & Yamane, H. (2020) · Cancers · doi:10.3390/cancers12071995 · Cited by 12 · see citing works
“In an Italian cohort of an expanded access program (EAP) using nivolumab for squamous NSCLC patients, 34% (n = 126), 47% (n = 175), and 19% (n = 70) of patients were aged <65, 65 to <75, and ≥75 years, respectively [35].”
BackgroundKim, Y.-J., Oremus, M., Chen, H., McFarlane, T., Shah, D. R., & Horton, S. (2020) · Future Oncology · doi:10.2217/fon-2020-0248 · Cited by 12 · see citing works
Okishio, K., Morita, R., Shimizu, J., Saito, H., Sakai, H., Kim, Y., Hataji, O., Yomota, M., Nishio, M., Aoe, K., et al. (2020) · ESMO Open · doi:10.1136/esmoopen-2019-000656 · Cited by 11 · see citing works
Guan, S., Ren, K., Zhang, X., Yan, M., Li, X., & Zhao, L. (2023) · Radiation Oncology · doi:10.1186/s13014-023-02305-5 · Cited by 12 · see citing works
“Notably, our study showed that elder was an independent factor favoring PFS, which is inconsistent with previous studies [25, 26].”
ResultRassy, E., Mezquita, L., Remon, J., & Besse, B. (2019) · Immunotherapy · doi:10.2217/imt-2019-0071 · Cited by 10 · see citing works
Safety of current immune checkpoint inhibitors in non-small cell lung cancer
Abdayem, P., & Planchard, D. (2021) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2021.1867100 · Cited by 11 · see citing works
“The incidence of grade 3–4 TRAEs was low in patients aged 65, 65–75 and ≥75 years and in the overall population (3%, 9%, 3%, 6%, respectively) [42].”
BackgroundAlexa‐Stratulat, T., Tanasa, M. P., Cianga, V. A., & Antoniu, S. A. (2022) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2022.2139242 · Cited by 11 · see citing works
Mortezaee, K., & Majidpoor, J. (2023) · Heliyon · doi:10.1016/j.heliyon.2023.e14566 · Cited by 11 · see citing works
Ciccarese, C., Iacovelli, R., Bria, E., Palazzo, A., Maiorano, B. A., Mosillo, C., Carbone, C., Piro, G., & Tortora, G. (2020) · Journal of Immunotherapy · doi:10.1097/cji.0000000000000312 · Cited by 10 · see citing works
CHOUAID, C., Thomas, M., Debieuvre, D., Durand‐Zaleski, I., Zacharias, S., Bosquet, L., Groth, A., Fleitz, A., Calleja, A., Patel, S., et al. (2022) · Cancers · doi:10.3390/cancers14246148 · Cited by 9 · see citing works
“This finding aligns with poor prognosis for patients with aNSCLC observed in some studies [17,20], although this association has not been observed in others [16,18,19,24,31].”
ResultPasello, G., Pavan, A., Nuzzo, M. D., Frega, S., Ferro, A., Maso, A. D., Bonanno, L., Guarneri, V., & Girardi, F. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1415470 · Cited by 9 · see citing works
Xiao, L., Liao, Y., Wang, J., Li, Q., Zhu, H., Hong, C., Li, R., He, J., Cui, H., Dong, H., et al. (2023) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-023-03417-3 · Cited by 8 · see citing works
“Retrospective studies including various types of cancer (urologic cancer, melanoma, and lung cancer) showed that the long-term clinical outcomes of ICIs were not statistically different between older and younger patients [13, 15, 24].”
BackgroundGogate, A., Bennett, B., Poonja, Z., Stewart, G. D., Medina, A., Szturz, P., Carrington, C., Castro, C., Gemmen, E., Lau, A., et al. (2023) · Cancers · doi:10.3390/cancers15143552 · Cited by 8 · see citing works
Zhang, R., Zhu, J., Liu, Y., Xin, Y., Wang, Y., Niu, K., & Wei, H. (2021) · Medicine · doi:10.1097/md.0000000000019713 · Cited by 8 · see citing works
“Due to the long 5-year survival rate of applying targeted drugs, immune therapy has been mostly applied in NSCLC patients without sensitive genes mutation, mainly the squamous cell lung carcinoma.([28,29]) But targeted drugs will be resistant as the time goes.”
BackgroundFerrara, R., Signorelli, D., Proto, C., Prelaj, A., Garassino, M. C., & Russo, G. L. (2021) · Translational Lung Cancer Research · doi:10.21037/tlcr-20-636 · Cited by 7 · see citing works
“On the other hand, a pooled analysis of three trials comparing pembrolizumab to chemotherapy in NSCLC patients (60), a phase II study of nivolumab including 34% of patients older than 70 years (61) and real-world data (62-65) showed a survival improvement with single agent ICI in the elderly population with no safety…”
BackgroundMethodGlobal research trends of immunosenescence: A bibliometric study
Chen, H., Luo, Y., Zhang, X., Luo, R., Bian, Y., Hou, Y., & Liu, Y. (2023) · Heliyon · doi:10.1016/j.heliyon.2023.e20362 · Cited by 7 · see citing works
Ron, D. A., Manrique, M. C. A., Mosquera, J., García, J., Afonso, F. J. A., Quintela, M. L., Núñez, N. F., Raposeiras, C. A., Amenedo, M., Couto, L. S., et al. (2020) · Journal of Geriatric Oncology · doi:10.1016/j.jgo.2020.11.010 · Cited by 7 · see citing works
Matsumoto, K., Tamiya, A., Inagaki, Y., Taniguchi, Y., Matsuda, Y., Kawachi, H., Tamiya, M., Tanizaki, S., Uchida, J., Ueno, K., et al. (2021) · Journal of Geriatric Oncology · doi:10.1016/j.jgo.2021.09.004 · Cited by 7 · see citing works
Azzi, L., Celesti, F., Chiaravalli, A. M., Shaik, A. K. B., Shallak, M., Gatta, A., Battaglia, P., Rosa, S. L., Tagliabue, A., Accolla, R. S., et al. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1387835 · Cited by 6 · see citing works
Kubo, T., Ichihara, E., Harada, D., Inoue, K., Fujiwara, K., Hosokawa, S., Kishino, D., Kawai, H., Ochi, N., Oda, N., et al. (2023) · Respiratory Investigation · doi:10.1016/j.resinv.2023.06.005 · Cited by 6 · see citing works
Checkpoint inhibitors in older patients with advanced non-small cell lung cancer
Reale, M. L., Romano, G. D., Paolelli, L., & Leo, S. (2023) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2023.104056 · Cited by 5 · see citing works
del Corral-Morales, J., Miguel, C. A.-D., Cortés, L. Q., Sanchez-Vegas, A., Aranda-Bellido, F., González-Santiago, S., Fuentes, J., & Miguel, P. A.-D. (2025) · Cancers · doi:10.3390/cancers17132194 · Cited by 5 · see citing works
“Few retrospective studies have assessed ICI outcomes by age, most of them reporting no major differences in efficacy across age groups, including patients aged over 80 years [17,19,31,32].”
Masuda, T., Fujitaka, K., Ishikawa, N., Nakano, K., Yamasaki, M., Kitaguchi, S., Masuda, K., Yamaguchi, K., Sakamoto, S., Horimasu, Y., et al. (2020) · Journal of Thoracic Disease · doi:10.21037/jtd.2019.12.46 · Cited by 4 · see citing works
Mourey, L., Rainho, L., Dalban, C., Carril-Ajuria, L., Négrier, S., Chevreau, C., Gravis, G., Thibault, C., Laguerre, B., Barthélémy, P., et al. (2024) · European Journal of Cancer · doi:10.1016/j.ejca.2024.113589 · Cited by 3 · see citing works
Overcoming frailty in recurrent and metastatic head and neck cancer
Szturz, P., & Vermorken, J. B. (2020) · Oral Oncology · doi:10.1016/j.oraloncology.2020.104636 · Cited by 3 · see citing works
Knetki‐Wróblewska, M., Kowalski, D. M., & Krzakowski, M. J. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9072273 · Cited by 3 · see citing works
Sebastian, M., Gröschel, A., Gütz, S., Schulz, H., Müller-Huesmann, H., Liersch, R., von der Heyde, E., Wiegand, J., Ukena, D., Bargon, J., et al. (2021) · Journal of Immunotherapy · doi:10.1097/cji.0000000000000397 · Cited by 3 · see citing works
“censored) 11/46 (35) 2/14 (12) 9/32 (23) OS Median (mo) [95% CI] 11.”
Efficacy and safety of immunotherapy in real-world patients with advanced non-small cell lung cancer
Yin, N., Yang, R., Liu, X., & Chen, X. (2025) · Cancer Treatment and Research Communications · doi:10.1016/j.ctarc.2025.100908 · Cited by 2 · see citing works
Efficacy of PD-1 Inhibitors in Older Non-small Cell Lung Cancer Patients
Nakamura, Y., Miyazaki, K., Aiko, N., Misumi, Y., Agemi, Y., Taniguchi, Y., Ishii, M., Shimokawa, T., Okamoto, H., & Yamanaka, T. (2020) · Anticancer Research · doi:10.21873/anticanres.14025 · Cited by 2 · see citing works
Rossi, S., Finocchiaro, G., Toschi, L., & Santoro, A. (2019) · Immunotherapy · doi:10.2217/imt-2019-0029 · Cited by 2 · see citing works
Wang, N., Wang, C., Wang, X., Meng, Y., Cui, S., Zhao, K., Jia, Y., & Kong, F. (2026) · Biochimica et Biophysica Acta (BBA) - Reviews on Cancer · doi:10.1016/j.bbcan.2026.189587 · Cited by 1 · see citing works
Nova, D., Pagliari, G. G., Mambrito, S., Cortinovis, D. L., & Canova, S. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1874841 · Cited by 1 · see citing works
“Likewise, data from the Italian expanded access program showed that nivolumab maintained a manageable safety pro fi le and meaningful clinical activity in elderly patients with advanced squamous NSCLC, supporting its use in this population (7).”
Traitement du cancer bronchique chez le sujet âgé
Corre, R., & Quoix, É. (2023) · Revue des Maladies Respiratoires Actualités · doi:10.1016/s1877-1203(23)00165-9 · Cited by 1 · see citing works
Yang, Z., Luo, Y., Lu, R., Liu, X., Liu, H., Liu, S., Huang, C., Tian, J., & Zhang, L. (2025) · Current Oncology · doi:10.3390/curroncol32040195 · Cited by 1 · see citing works
Radiotherapy and Systemic Anti-Cancer Treatment in Older Adults with Cancer and Frailty
O’Donovan, A., Baldini, C., & Battisti, N. M. L. (2022) · Springer eBooks · doi:10.1007/978-3-030-89162-6_14 · Cited by 1 · see citing works
Tumors: Non-small Cell Lung Cancer
Corre, R. (2021) · Springer eBooks · doi:10.1007/978-3-319-69892-2_779-1 · Cited by 1 · see citing works
Checkpoint Inhibitors in Squamous Non-Small Cell Lung Cancer (NSCLC)
Khamar, B. M. (2018) · Open Access Journal of Oncology and Medicine · doi:10.32474/oajom.2018.02.000140
“Nivolumab in Elderly Nivolumab has also been evaluated as a monotherapy in a single arm study in 371 elderly patients with Sq NSCLC following progression [17].”
BackgroundInfluentialPrise en charge du cancer bronchique non à petites cellules chez les sujets âgés
Corre, R. (2020) · Revue des Maladies Respiratoires Actualités · doi:10.1016/s1877-1203(20)30108-7
Prise en charge du cancer bronchique non à petites cellules chez les sujets âgés
Corre, R., Andre, M., Vergne, F., & Chiappa, A. M. (2021) · Revue des Maladies Respiratoires Actualités · doi:10.1016/s1877-1203(21)00123-3
Tumors: Non-small Cell Lung Cancer
Corre, R. (2021) · Springer eBooks · doi:10.1007/978-3-030-22009-9_779
Kurokawa, K., Mitsuishi, Y., Shimada, N., Kawakami, Y., Miura, K., Miyawaki, T., Asao, T., Ko, R., Shukuya, T., Shibayama, R., et al. (2022) · Research Square · doi:10.21203/rs.3.rs-1452477/v1
(2021) · International Journal on Oncology and Radiotherapy · doi:10.51626/ijor.2021.02.00007
Traitements systémiques du cancer bronchique non à petites cellules chez les sujets âgés
Pabst, L., Corre, R., & Quoix, É. (2022) · Revue des Maladies Respiratoires Actualités · doi:10.1016/s1877-1203(22)00136-7
- Authors
- Grossi, F., Crinò, L., Logroscino, A., Canova, S., Delmonte, A., Melotti, B., Proto, C., Gelibter, A., Cappuzzo, F., Turci, D., Gamucci, T., Antonelli, P., Marchetti, P., Santoro, A., Giusti, S., Di Costanzo, F., Giustini, L., Del Conte, A., Livi, L., Giannarelli, D., & de Marinis, F.
- Affiliations
- Ospedale Policlinico San Martino (IT)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Istituto Tumori Bari (IT)
- Azienda Ospedaliera San Gerardo (IT)
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- Sapienza University of Rome (IT)
- Ospedale "Santa Maria delle Croci" di Ravenna (IT)
- Ospedale di Circolo di Busto Arsizio (IT)
- Azienda Ospedaliera Sant'Andrea (IT)
- Azienda Ospedaliero-Universitaria Careggi (IT)
- Instituto Nazionale Tumori Regina Elena (IT)
- Corresponding author
- Grossi, Francesco
- ORCID
- Venue
- European Journal of Cancer
- Publisher
- Elsevier BV
- Published
- 2018-09
- Volume
- 100
- Pages
- 126-134
- ISSN
- 0959-8049 (ISSN-L)
- OpenAlex
- W2884761157
- Cited by
- 111
- References
- 33
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 8 · 2023: 13 · 2022: 12 · 2021: 21 · 2020: 27 · 2019: 13 · 2018: 4
- FWCI
- 6.10
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Cancer (publishedVersion)
- PubMed (publishedVersion)
- Florence Research (University of Florence) (submittedVersion)
- IrInSubria (University of Insubria) (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- nivolumab, lung squamous cell carcinoma, elderly patients, immune checkpoint inhibitors, expanded access program, treatment-related adverse events, objective response rate, overall survival, age-stratified analysis
- MeSH terms
- Antineoplastic Agents, Immunological, Nivolumab, Adult, Age Factors, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Humans, Italy, Lung Neoplasms, Male, Middle Aged, Time Factors, Treatment Outcome, Compassionate Use Trials
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