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A phase II study of pembrolizumab and paclitaxel in patients with relapsed or refractory small-cell lung cancer

Cited 7 time in Web of Science Cited 9 time in Scopus
Authors
Kim, Yu-Jung; Keam, Bhumsuk; Ock, Chan-Young; Song, Sanghoon; Kim, Miso; Kim, Se Hyun; Kim, Ki Hwan; Kim, Jin-Soo; Kim, Tae Min; Kim, Dong-Wan; Lee, Jong Seok; Heo, Dae Seog
Issue Date
2019-10
Citation
Lung Cancer, Vol.136, pp.122-128
Keywords
PembrolizumabPaclitaxelSmall-cell lung cancer
Abstract
Objective: Patients with etoposide/platinum-refractory extensive disease (ED) small-cell lung cancer (SCLC) have a dismal prognosis. We aimed to evaluate the efficacy and safety of pembrolizumab and paclitaxel combination therapy in these patients. Methods: In this multi-center, phase II study, ED-SCLC patients who showed progression after etoposide/platinum chemotherapy received paclitaxel 175 mg/m(2) every 3 weeks for up to six cycles. Pembrolizumab 200 mg was added from the second cycle and continued until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), safety, and biomarker analyses including programmed death-ligand 1 (PD-L1) expression, next-generation sequencing, and flow cytometric analysis of peripheral blood cells. Results: Of the 26 patients enrolled, the confirmed ORR was 23.1% (95%CI: 6.9%-39.3%); complete response: 3.9%, confirmed partial response [PR]: 19.2%, stable disease: 57.7%, progressive disease: 7.7%, and not evaluable: 11.5%. Including 4 cases of unconfirmed PRs, 38.5% of patients were responding and the disease control rate was 80.7%. The median PFS and OS were 5.0 months (95% CI: 2.7-6.7) and 9.1 months (95% CI: 6.5-15.0), respectively. The grade 3 or 4 adverse events observed included febrile neutropenia (7.7%), neutropenia (7.7%), asthenia (7.7%), hyponatremia (7.7%), and type I diabetes (7.7%). Targeted gene sequencing identified no specific genetic alterations correlated with the treatment, except for theMET copy number gain (PFS 10.5 versus 3.4 months, p = 0.019). Conclusions: Pembrolizumab and paclitaxel combination therapy showed a moderate activity with acceptable toxicity in patients with refractory ED-SCLC.
ISSN
0169-5002
URI
https://hdl.handle.net/10371/165212
DOI
https://doi.org/10.1016/j.lungcan.2019.08.031
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College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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