TY - JOUR
T1 - First-line durvalumab plus platinum-etoposide in extensive-stage small-cell lung cancer
T2 - CASPIAN Japan subgroup analysis
AU - Hotta, Katsuyuki
AU - Nishio, Makoto
AU - Saito, Haruhiro
AU - Okamoto, Isamu
AU - Nakahara, Yasuharu
AU - Hayashi, Hidetoshi
AU - Hayama, Manabu
AU - Laud, Peter
AU - Jiang, Haiyi
AU - Paz-Ares, Luis
AU - Azuma, Koichi
N1 - Funding Information:
Katsuyuki Hotta has received research funding from AstraZeneca, Chugai, Eli Lilly, Bristol-Myers Squibb, and Astellas, and lecture fees/honoraria/other fees from MSD and AstraZeneca. Makoto Nishio has received research funding from Chugai, AstraZeneca, Ono, Bristol-Myers Squibb, Pfizer, Eli Lilly, Boehringer Ingelheim, MSD, Novartis, Taiho, Daiichi Sankyo, Merck Serono, and Astellas, and lecture fees/honoraria/other fees from Chugai, AstraZeneca, Ono, Bristol-Myers Squibb, Pfizer, Eli Lilly, Taiho, Boehringer Ingelheim, MSD, Novartis, and Daiichi Sankyo. Haruhiro Saito has received research funding from Chugai and AstraZeneca. Isamu Okamoto has received research funding from Bristol-Myers Squibb, Chugai, AstraZeneca, Boehringer Ingelheim, AbbVie, Daiichi Sankyo, Taiho, and Ono, lecture fees/honoraria/other fees from Eli Lilly, Chugai, AstraZeneca, MSD, and Pfizer, and scholarship (incentive) endowments from Eli Lilly, Chugai, Boehringer Ingelheim, Taiho, and Ono. Hidetoshi Hayashi has received research funding from AstraZeneca, Boehringer Ingelheim, Ono, and Chugai, and lecture fees/honoraria/other fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Eli Lilly, Kyorin, MSD, Ono, Pfizer, and Taiho. Manabu Hayama and Haiyi Jiang are full-time employees of AstraZeneca. Peter Laud is contracted to AstraZeneca from the Statistical Services Unit at the University of Sheffield, which received funding from AstraZeneca. Luis Paz-Ares has received research funding from Bristol-Myers Squibb and AstraZeneca, and lecture fees/honoraria/other fees from MSD, AstraZeneca, Roche, Bristol-Myers Squibb, and Eli Lilly. Koichi Azuma has received research funding from AstraZeneca, MSD, Bristol-Myers Squibb, Ono, and Chugai, and lecture fees/honoraria/other fees from AstraZeneca, MSD, Bristol-Myers Squibb, Ono, and Chugai. Yasuharu Nakahara has no conflicts of interest to declare.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/6
Y1 - 2021/6
N2 - Background: In the phase 3 CASPIAN study (NCT03043872), first-line durvalumab plus etoposide and cisplatin or carboplatin (EP) significantly improved OS versus EP alone in patients with extensive-stage (ES)-SCLC (HR 0.73 [95% CI 0.59–0.91; p = 0.0047]). Here we report results for a preplanned subgroup analysis of patients recruited in Japan. Methods: Treatment-naïve patients with ES-SCLC received either 4 cycles of durvalumab 1500 mg plus EP q3w followed by maintenance durvalumab 1500 mg q4w until disease progression or up to 6 cycles of EP q3w. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and tolerability. Results: In the Japan subgroup, 18 patients were randomized to durvalumab plus EP and 16 patients to EP. At the interim analysis with a median follow-up of 12.5 months in the subgroup, OS numerically favored durvalumab plus EP versus EP (HR 0.77 [95% CI 0.26‒2.26]; median not reached vs 15.2 months). PFS was similar for durvalumab plus EP versus EP (HR 0.90 [95% CI 0.43‒1.89]). Confirmed ORR was 89% with durvalumab plus EP versus 69% with EP. Adverse events (AEs) of CTCAE grade 3 or 4 were reported in 78% versus 94% of patients in the durvalumab plus EP versus EP arms. There were no AEs leading to treatment discontinuation or death in the Japan subgroup. Conclusion: First-line durvalumab plus EP was effective and well tolerated in Japanese patients with ES-SCLC. Despite the small size of the Japan subgroup, results were generally consistent with the global study population.
AB - Background: In the phase 3 CASPIAN study (NCT03043872), first-line durvalumab plus etoposide and cisplatin or carboplatin (EP) significantly improved OS versus EP alone in patients with extensive-stage (ES)-SCLC (HR 0.73 [95% CI 0.59–0.91; p = 0.0047]). Here we report results for a preplanned subgroup analysis of patients recruited in Japan. Methods: Treatment-naïve patients with ES-SCLC received either 4 cycles of durvalumab 1500 mg plus EP q3w followed by maintenance durvalumab 1500 mg q4w until disease progression or up to 6 cycles of EP q3w. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and tolerability. Results: In the Japan subgroup, 18 patients were randomized to durvalumab plus EP and 16 patients to EP. At the interim analysis with a median follow-up of 12.5 months in the subgroup, OS numerically favored durvalumab plus EP versus EP (HR 0.77 [95% CI 0.26‒2.26]; median not reached vs 15.2 months). PFS was similar for durvalumab plus EP versus EP (HR 0.90 [95% CI 0.43‒1.89]). Confirmed ORR was 89% with durvalumab plus EP versus 69% with EP. Adverse events (AEs) of CTCAE grade 3 or 4 were reported in 78% versus 94% of patients in the durvalumab plus EP versus EP arms. There were no AEs leading to treatment discontinuation or death in the Japan subgroup. Conclusion: First-line durvalumab plus EP was effective and well tolerated in Japanese patients with ES-SCLC. Despite the small size of the Japan subgroup, results were generally consistent with the global study population.
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U2 - 10.1007/s10147-021-01899-8
DO - 10.1007/s10147-021-01899-8
M3 - Article
C2 - 33826027
AN - SCOPUS:85103940579
VL - 26
SP - 1073
EP - 1082
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
IS - 6
ER -