Abstract 1160P
Background
The CAPITAL study, a randomized phase III trial, was conducted to compare carboplatin and nab-paclitaxel (nab-P/C) with docetaxel (D) for treating elderly patients with squamous-cell lung cancer.
Methods
We performed a safety analysis for patients ≥75 and <75 years old from each treatment group, post-hoc analysis of the impact of second-line immune checkpoint inhibitors (ICI) on survival, and intra-cycle nab-paclitaxel skip status.
Results
The common adverse events (AEs) in the nab-P/C group were leucopenia, neutropenia, and anemia, while leucopenia, neutropenia, and febrile neutropenia were common in the D group. In the D group, there was a high frequency of AEs, particularly neutropenia for patients ≥75. In the nab-P/C group, the common AEs were anemia and thrombocytopenia for those patients. Thirty-eight percent (74/190) of the patients were transferred to the second-line ICI treatment, 36 and 38 patients from the nab-P/C and D groups, respectively. The overall survival of patients on ICI depended on their reason for discontinuing the first treatment. In both groups, improvement of overall survival was observed in patients with disease progression after first-line therapy. Median overall survival after discontinuation of nab-P/C was 321 d with ICI and 142 d without ICI; in the D group, it was 311 d with ICI and 256 d without ICI. However, no survival benefit was seen in patients who discontinued due to AEs. Their median overall survival after discontinuing nab-P/C was 224 d with ICI and 373 d without ICI; after discontinuing D, the median overall survival was 186.5 d with ICI and 154 d without ICI. In cycle one and two, 10%–30% of patients skipped taking nab-paclitaxel, and over 50% skipped taking it after cycle 3.
Conclusions
Nab-P/C improved overall survival more than D in elderly patients with advanced or recurrent squamous cell lung cancer. ICI treatment did not improve the overall survival of patients in both groups, who discontinued the first line treatment due to AEs. Nab-P/C did not show a significant increase in toxicity in patients over 75 y of age. Many patients skipped nab-paclitaxel within cycles.
Clinical trial identification
UMIN000019843; jRCTs041180110.
Editorial acknowledgement
Legal entity responsible for the study
NHO Nagoya Medical Center.
Funding
Taiho Pharmaceutical.
Disclosure
Y. Kogure: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Chugai Pharmaceutical, Taiho Pharmaceutical, Eli Lilly, Boehringer Ingelheim, Ono Pharmaceutical; Financial Interests, Institutional, Invited Speaker: MSD, Taiho Pharmaceutical. A. Kada: Financial Interests, Institutional, Funding: Taiho Pharmaceutical. S. Atagi: Financial Interests, Personal, Invited Speaker: Eli Lilly, AstraZeneca, Ono, Taiho Pharmaceutical, Boehringer Ingelheim, Pfizer, Bristol Myers Squibb, Hisamitsu, MSD, Eli Lilly, Chugai, Kyowa Hakko Kirin, Merck, Novartis Pharma, Thermo Fisher Scientific; Non-Financial Interests, Personal, Other: Roche. Y. Takiguchi: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Taiho Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, Pfizer, Bristol Meyers Squib, MSD, Daiichi Sankyo, Japan Eli Lilly, Boehringer Ingelheim, Kyowa-Kirin; Financial Interests, Personal, Research Grant: Ono Pharmaceutical, Taiho Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, Bristol Meyers Squib, MSD, Merck, Japan Eli Lilly, Takeda, Boehringer Ingelheim, Daiichi Sankyo. H. Saka: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Boehringer, Boston Scientific, Covidien, Ono, Taiho, Ili Lilly, MSD, Becton Dickinson, Chugai, Amco, Kyowa Hakko Kirin, Kyorin, Pfizer, Novartis Pharma, Fuji Film TOyama; Financial Interests, Institutional, Funding: AstraZeneca, MSD, Ono, Ili Lilly, Bristol Meyers, Chugai, Beyer, Olympus, Boehringer, Novartis Pharma, Pfizer, Takeda, Otsuka, Harada, Nobeopharma, Celgene, Taisho Toyama. A. Inoue: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Eli Lilly, Boehringer Ingelheim, Chugai, Daiichi Sankyo, MSD, Ono. T. Kurata: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, MSD, Eli Lilly, Chugai, Ono, Bristol Myers, Boehringer Ingelheim, Pfizer; Financial Interests, Personal, Principal Investigator: AstraZeneca, MSD, Ono, Eli Lilly, Takeda. Y. Fujita: Financial Interests, Personal, Invited Speaker: Lilly, Chugai Pharmaceutical, AstraZeneca, Taiho Pharmaceutical; Financial Interests, Institutional, Funding: Lilly, Pfizer, Chugai Pharmaceutical, Taiho Pharmaceutical. Y. Nishii: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Novartis pharma, Boehringer Ingelheim, Bayer Yakuhin, Glaxo SmithKline. T. Shibayama: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Boehringer Ingelheim, Novartis International AG; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutica, Ono Pharmaceutical, Merck; Financial Interests, Personal, Expert Testimony: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca, Boehringer Ingelheim, Novartis International AG, Merck, bostonscientific.com, Pfizer, EP-CRSU Co., Ltd., Okayama University, National Hospital Organization Nagoya Medical Center, Shimane University, West Japan Oncology Group; Financial Interests, Institutional, Funding: Ono Pharmaceutical. H. Itani: Financial Interests, Personal, Speaker’s Bureau: Eli Lilly, Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Bristol Myers, MSD; Financial Interests, Institutional, Funding: Chugai Pharmaceutical. N. Yamamoto: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Ono Pharmaceutical, Daiichi Sankyo, Thermo Fisher Scientific, Daiichi Sankyo, Takeda Pharmaceutical, Chugai Pharmaceutical, Eli Lilly Japan, Boehringer Ingelheim, Novartis, Pfizer, Bristol Myers Squibb, Nippon Kayaku, GlaxoSmithKline, Sanofi, Hisamitsu Pharmaceutical, Merk biopharma, Guardant Health Japan; Financial Interests, Institutional, Advisory Role: AstraZeneca, MSD, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda Pharmaceutical, Chugai Pharmaceutical, Eli Lilly Japan, Boehringer Ingelheim, Novartis, Pfizer, Bristol-Myers Squibb, Nippon Kayaku, Life Technologies Japan, Amgen, Guardant Health Japan, Janssen Pharmaceutical; Financial Interests, Personal, Funding: Chugai Pharmaceutical, Boehringer Ingelheim, Tosoh Life Science Research Laboratory; Financial Interests, Institutional, Funding: AstraZeneca, Boehringer Ingelheim, Otsuka Pharmaceutica, Chugai Pharmaceutical, Shionogi, Daiichi Sankyo, Eli Lilly Japan, Tsumura, Nippon Kayaku, Asahi Kasei Pharma, Janssen Pharmaceutical, Taiho Pharmaceutical, Sanofi, Amgen. A. Gemma: Financial Interests, Personal, Invited Speaker: Pfizer, Ono, Boehringer, Taiho, Kyowakirin, AstraZeneca, Chugai, Novartis, Bristol; Financial Interests, Personal, Advisory Board: MSD, Nihon Kayaku, Daiichi Sankyo. All other authors have declared no conflicts of interest.