The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.
Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation
Open accessAbstract
PURPOSE: Five percent to 9% of pancreatic ductal adenocarcinomas (PDACs) develop in patients with a germline BRCA1/2 or PALB2 (g BRCA/PALB2+) mutation. Phase IB data from a trial that used cisplatin, gemcitabine, and veliparib treatment demonstrated a high response rate (RR), disease control rate (DCR), and overall survival (OS) in this population. We designed an open-label, randomized, multicenter, two-arm phase II trial to investigate cisplatin and gemcitabine with or without veliparib in g BRCA/PALB2+ PDAC. PATIENTS AND METHODS: Eligible patients had untreated g BRCA/PALB2+ PDAC with measurable stage III to IV disease and Eastern Cooperative Oncology Group performance status of 0 to 1. Treatment for patients in arm A consisted of cisplatin 25 mg/m 2 and gemcitabine 600 mg/m 2 intravenously on days 3 and 10; treatment for patients in arm B was the same as that for patients in arm A, and arm A also received veliparib 80 mg orally twice per day on days 1 to 12 cycled every 3 weeks. The primary end point was RRs of arm A and arm B evaluated separately using a Simon two-stage design. Secondary end points were progression-free survival, DCR, OS, safety, and correlative analyses. RESULTS: Fifty patients were evaluated by modified intention-to-treat analysis. The RR for arm A was 74.1% and 65.2% for arm B ( P = .55); both arms exceeded the prespecified activity threshold. DCR was 100% for arm A and 78.3% for arm B ( P = .02). Median progression-free survival was 10.1 months for arm A (95% CI, 6.7 to 11.5 months) and 9.7 months for arm B (95% CI, 4.2 to 13.6 months; P = .73). Median OS for arm A was 15.5 months (95% CI, 12.2 to 24.3 months) and 16.4 months for arm B (95% CI, 11.7 to 23.4 months; P = .6). Two-year OS rate for the entire cohort was 30.6% (95% CI, 17.8% to 44.4%), and 3-year OS rate was 17.8% (95% CI, 8.1% to 30.7%). Grade 3 to 4 hematologic toxicities for arm A versus arm B were 13 (48%) versus seven (30%) for neutropenia, 15 (55%) versus two (9%) for thrombocytopenia, and 14 (52%) versus eight (35%) for anemia. CONCLUSION: Cisplatin and gemcitabine is an effective regimen in advanced g BRCA/PALB2+ PDAC. Concurrent veliparib did not improve RR. These data establish cisplatin and gemcitabine as a standard approach in g BRCA/ PALB2+ PDAC.
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FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer
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Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine
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Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy
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Optimal two-stage designs for phase II clinical trials.
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Maintenance Olaparib for Germline BRCA -Mutated Metastatic Pancreatic Cancer
Golan, T., Hammel, P., Reni, M., Van Cutsem, E., Macarulla, T., Hall, M. J., Park, J.-O., Hochhauser, D., Arnold, D., Oh, D.-Y., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1903387 · Cited by 2,302
Self-citationAudeh, M. W., Carmichael, J., Penson, R. T., Friedlander, M., Powell, B., Bell-McGuinn, K. M., Scott, C., Weitzel, J. N., Oaknin, A., Loman, N., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(10)60893-8 · Cited by 2,279
Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT)
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Kindler, H. L., Hammel, P., Reni, M., Van Cutsem, E., Macarulla, T., Hall, M. J., Park, J. O., Hochhauser, D., Arnold, D., Oh, D.-Y., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.21.01604 · Cited by 244
Self-citationThe pancreatic cancer genome revisited
Hayashi, A., Hong, J., & Iacobuzio-Donahue, C. A. (2021) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-021-00463-z · Cited by 211
Pancreas cancer and BRCA : A critical subset of patients with improving therapeutic outcomes
Momtaz, P., O’Connor, C. A., Chou, J. F., Capanu, M., Park, W., Bandlamudi, C., Berger, M. F., Kelsen, D. P., Suehnholz, S. P., Chakravarty, D., et al. (2021) · Cancer · doi:10.1002/cncr.33812 · Cited by 44
Self-citationTargeting DNA damage repair pathways in pancreas cancer
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Metadata
- Authors
- O’Reilly, E. M., Lee, J. W., Zalupski, M., Capanu, M., Park, J., Golan, T., Tahover, E., Lowery, M. A., Chou, J. F., Sahai, V., Brenner, R., Kindler, H. L., Yu, K. H., Zervoudakis, A., Vemuri, S., Stadler, Z. K., Do, R. K. G., Dhani, N., Chen, A. P., & Kelsen, D. P.
- Venue
- Journal of Clinical Oncology
- Published
- 2020-05-01
- Volume
- 38
- Issue
- 13
- Pages
- 1378-1388
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3001713806
- Cited by
- 404
- References
- 34
- FWCI
- 21.41
- Type
- journal article
- Language
- en
- Open access
- green
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- O’Reilly, E. M., Lee, J. W., Zalupski, M., Capanu, M., Park, J., Golan, T., Tahover, E., Lowery, M. A., Chou, J. F., Sahai, V., Brenner, R., Kindler, H. L., Yu, K. H., Zervoudakis, A., Vemuri, S., Stadler, Z. K., Do, R. K. G., Dhani, N., Chen, A. P., & Kelsen, D. P. (2020). Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation. Journal of Clinical Oncology. https://doi.org/10.1200/jco.19.02931
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