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First-line pembrolizumab?±?chemotherapy for recurrent/metastatic head and neck cancer: Japanese subgroup of KEYNOTE-048 |
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| Authors: | Takahashi Shunji Oridate Nobuhiko Tanaka Kaoru Shimizu Yasushi Fujimoto Yasushi Matsumoto Koji Yokota Tomoya Yamazaki Tomoko Takahashi Masanobu Ueda Tsutomu Hanai Nobuhiro Yamaguchi Hironori Hara Hiroki Yoshizaki Tomokazu Yasumatsu Ryuji Nakayama Masahiro Shiga Kiyoto Fujii Takashi Mitsugi Kenji Takahashi Kenichi Nohata Nijiro Gumuscu Burak Swaby Ramona F Tahara Makato |
| Institution: | 1.Cancer Institute Hospital, Japanese Foundation For Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8500, Japan ;2.Yokohama City University Graduate School of Medicine, 4-57 Urafune, Minami-ku, Yokohama, 236-0004, Japan ;3.Kindai University Hospital, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan ;4.Hokkaido University Hospital, 5 Chome Kita 14 Jonishi, Kita Ward, Sapporo, Hokkaido, 060-8648, Japan ;5.Aichi Medical University Hospital, Yazako, Karimata-1-1, Nagakute, Aichi, 480-1195, Japan ;6.Hyogo Cancer Center, 1370 Akashi, Hyogo, 673-0021, Japan ;7.Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Sunto District, Shizuoka, 411-8777, Japan ;8.Miyagi Cancer Center, 47-1 Nodayama Medeshimashiote, Natori, Miyagi, 981-1293, Japan ;9.Tohoku University Hospital, 1-1 Seiryomachi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan ;10.Hiroshima University Hospital, 1 Chome-2-3 Kasumi, Minami Ward, Hiroshima, 734-8551, Japan ;11.Aichi Cancer Center, Yazako, Karimata-1-1, Nagakute, Aichi, 480-1195, Japan ;12.Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan ;13.Saitama Cancer Center, 780 Komuro, Ina, Kitaadachi District, Saitama, 362-0806, Japan ;14.Kanazawa University, Kakumamachi, Kanazawa, Ishikawa, 920-1192, Japan ;15.Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0935, Japan ;16.Tsukuba University, 1 Chome-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan ;17.Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-0023, Japan ;18.Osaka International Cancer Institute, 1-3-3 Nakamichi, Tosei-ku, Osaka, 537-8511, Japan ;19.Hamanomachi Hospital, 3-chōme-3-1 Nagahama, Chuo Ward, Fukuoka, 810-8539, Japan ;20.MSD K.K., Kitanomaru Square, 1-chōme-13-12 Kudankita, Chiyoda City, Tokyo, 102-0073, Japan ;21.Merck & Co., Inc., 126 E Lincoln Ave, Rahway, NJ, 07065, USA ;23.National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan ; |
| Abstract: | Background Here, we report the results of the Japanese subgroup of the phase 3 KEYNOTE-048 study of pembrolizumab alone, pembrolizumab plus platinum and 5-fluorouracil (pembrolizumab–chemotherapy), or cetuximab plus platinum and 5-fluorouracil (EXTREME) in previously untreated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). MethodsPrimary end points were overall survival (OS) and progression-free survival (PFS). Efficacy was evaluated in patients with PD-L1 combined positive score (CPS) ≥?20 and ≥?1 and the total Japanese subgroup (n?=?67). ResultsAt data cutoff (25 February 2019), pembrolizumab led to longer OS versus EXTREME in the PD-L1 CPS ≥?20 subgroup (median, 28.2 vs. 13.3 months; HR, 0.29 95% CI 0.09–0.89]) and to similar OS in the total Japanese (23.4 vs. 13.6 months; HR, 0.51 95% CI 0.25–1.05]) and CPS ≥?1 subgroups (22.6 vs. 15.8 months; HR, 0.66 95% CI 0.31–1.41]). Pembrolizumab–chemotherapy led to similar OS versus EXTREME in the PD-L1 CPS ≥?20 (median, 18.1 vs. 15.8 months; HR, 0.72 95% CI 0.23–2.19]), CPS?≥?1 (12.6 vs. 15.8 months; HR, 1.19 95% CI 0.55–2.58]), and total Japanese subgroups (12.6 vs. 13.3 months; unadjusted HR, 1.10 95% CI 0.55–2.22]). Median PFS was similar for pembrolizumab and pembrolizumab–chemotherapy versus EXTREME in all subgroups. Grades 3–5 treatment-related adverse events occurred in 5 (22%), 19 (76%), and 17 (89%) patients receiving pembrolizumab, pembrolizumab–chemotherapy, and EXTREME, respectively. One patient receiving pembrolizumab–chemotherapy died because of treatment-related pneumonitis. ConclusionThese results support the use of first-line pembrolizumab and pembrolizumab–chemotherapy for Japanese patients with R/M HNSCC. Clinical trial registry ClinicalTrials.gov, NCT02358031. |
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