Cheol-Kyu Park1, In-Jae Oh1, Kyu-Sik Kim1, Yoo-Duk Choi2, Tae-Won Jang3, Youn-Seup Kim4, Kwan-Ho Lee5, Kyeong-Cheol Shin5, Chi Young Jung6, Sei-Hoon Yang7, Jeong-Seon Ryu8, Seung-Hun Jang9, Seung-Soo Yoo10, Suk-Joong Yong11, Kye Young Lee12, Kwang-Ho In13, Min-Ki Lee14, Young-Chul Kim15. 1. Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea. 2. Department of Pathology, Chonnam National University Medical School, Gwangju, Korea. 3. Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea. 4. Department of Internal Medicine, Dankook University Hospital, Cheonan, Korea. 5. Department of Internal Medicine, Youngnam University Hospital, Daegu, Korea. 6. Department of Internal Medicine, Daegu Catholic University Hospital, Daegu, Korea. 7. Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea. 8. Department of Internal Medicine, Inha University Hospital, Incheon, Korea. 9. Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea. 10. Department of Internal Medicine, Kyungpook National University Chilgok Hospital, Daegu, Korea. 11. Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea. 12. Department of Internal Medicine, Konkuk University Hospital, Seoul, Korea. 13. Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea. 14. Department of Internal Medicine, Pusan National University Hospital, Busan, Korea. 15. Department of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam, Korea. Electronic address: kyc0923@jnu.ac.kr.
Abstract
INTRODUCTION: To date, no prospective phase III trials have directly compared the efficacy of pemetrexed plus cisplatin (Pem-Cis) with docetaxel plus cisplatin (Doc-Cis) in patients with nonsquamous non-small-cell lung cancer. MATERIALS AND METHODS: A total of 148 chemotherapy-naive patients lacking driver mutations were randomized into 21-day regimens of cisplatin 70 mg/m2 with either docetaxel 60 mg/m2 (n = 71) or pemetrexed 500 mg/m2 (n = 77) for ≤ 4 cycles. The primary objective was to assess the noninferiority of progression-free survival (PFS) for patients receiving the Doc-Cis regimen. The secondary endpoints were the response rates, overall survival, and toxicity profiles. RESULTS:Partial remission was observed in 24 (31.2%) and 24 (33.8%) patients in the Pem-Cis and Doc-Cis groups, respectively. The median PFS was 4.7 months (95% confidence interval [CI], 4.4-5.0) in the Pem-Cis arm and 4.4 months (95% CI, 3.7-5.1) in the Doc-Cis arm (P > .05). The median overall survival was longer in the Doc-Cis arm (13.3 months; 95% CI, 8.1-18.5) than in the Pem-Cis arm (11.7 months; 95% CI, 8.6-14.8; P > .05). Between the 2 arms, no significant difference was found in the subsequent treatments after failure of first-line treatment. The rate of grade 3 or 4 neutropenia and febrile neutropenia was greater in the Doc-Cis arm than in the Pem-Cis arm. CONCLUSION: In nonsquamous non-small-cell lung cancer patients lacking driver mutations, the PFS and response rates were similar between the 2 arms, and toxicity was tolerable, although adverse events and more severe toxicities were observed more frequently in the Doc-Cis arm.
RCT Entities:
INTRODUCTION: To date, no prospective phase III trials have directly compared the efficacy of pemetrexed plus cisplatin (Pem-Cis) with docetaxel plus cisplatin (Doc-Cis) in patients with nonsquamous non-small-cell lung cancer. MATERIALS AND METHODS: A total of 148 chemotherapy-naive patients lacking driver mutations were randomized into 21-day regimens of cisplatin 70 mg/m2 with either docetaxel 60 mg/m2 (n = 71) or pemetrexed 500 mg/m2 (n = 77) for ≤ 4 cycles. The primary objective was to assess the noninferiority of progression-free survival (PFS) for patients receiving the Doc-Cis regimen. The secondary endpoints were the response rates, overall survival, and toxicity profiles. RESULTS: Partial remission was observed in 24 (31.2%) and 24 (33.8%) patients in the Pem-Cis and Doc-Cis groups, respectively. The median PFS was 4.7 months (95% confidence interval [CI], 4.4-5.0) in the Pem-Cis arm and 4.4 months (95% CI, 3.7-5.1) in the Doc-Cis arm (P > .05). The median overall survival was longer in the Doc-Cis arm (13.3 months; 95% CI, 8.1-18.5) than in the Pem-Cis arm (11.7 months; 95% CI, 8.6-14.8; P > .05). Between the 2 arms, no significant difference was found in the subsequent treatments after failure of first-line treatment. The rate of grade 3 or 4 neutropenia and febrile neutropenia was greater in the Doc-Cis arm than in the Pem-Cis arm. CONCLUSION: In nonsquamous non-small-cell lung cancerpatients lacking driver mutations, the PFS and response rates were similar between the 2 arms, and toxicity was tolerable, although adverse events and more severe toxicities were observed more frequently in the Doc-Cis arm.
Authors: Alastair Greystoke; Nicola Steele; Hendrik-Tobias Arkenau; Fiona Blackhall; Noor Md Haris; Colin R Lindsay; Raffaele Califano; Mark Voskoboynik; Yvonne Summers; Karen So; Dana Ghiorghiu; Angela W Dymond; Stuart Hossack; Ruth Plummer; Emma Dean Journal: Br J Cancer Date: 2017-08-24 Impact factor: 7.640
Authors: Jan A Stratmann; Raphael Lacko; Olivier Ballo; Shabnam Shaid; Wolfgang Gleiber; Maria J G T Vehreschild; Thomas Wichelhaus; Claudia Reinheimer; Stephan Göttig; Volkhard A J Kempf; Peter Kleine; Susanne Stera; Christian Brandts; Martin Sebastian; Sebastian Koschade Journal: PLoS One Date: 2020-11-25 Impact factor: 3.240
Authors: Kristian Brat; Monika Bratova; Jana Skrickova; Magda Barinova; Karolina Hurdalkova; Milos Pesek; Libor Havel; Leona Koubkova; Michal Hrnciarik; Jana Krejci; Ondrej Fischer; Milada Zemanova; Helena Coupkova; Martin Svaton Journal: Thorac Cancer Date: 2020-10-05 Impact factor: 3.500