1292P - Safety data from randomized phase II study of cisplatin (CDDP)+S-1 versus CDDP+pemetrexed (PEM) combined with thoracic radiotherapy (TRT) for local...

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Cancer in Adolescents
Non-Small-Cell Lung Cancer, Locally Advanced
Lung and other Thoracic Tumours
Surgery and/or Radiotherapy of Cancer
Presenter Seiji Niho
Citation Annals of Oncology (2017) 28 (suppl_5): v457-v459. 10.1093/annonc/mdx379
Authors S. Niho1, T. Yoshida2, T. Akimoto3, K. Sakamaki4, T. Takahashi5, T. Seto6, M. Nishio7, N. Yamamoto8, T. Hida9, H. Okamoto10, T. Kurata11, M. Satouchi12, K. Goto1, T. Yamanaka4, Y. Ohe8
  • 1Department Of Thoracic Oncolgoy, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2Department Of Thoracic Oncology, Aichi Cancer Center Hospital, 464-8681 - Aichi/JP
  • 3Department Of Radiation Oncolgoy, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 4Department Of Biostatistics, Yokohama City University School of Medicine, 236-0004 - Yokohama/JP
  • 5Division Of Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 6Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - FUKUOKA/JP
  • 7Department Of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 135-8550 - Tokyo/JP
  • 8Department Of Thoracic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 9Department Of Thoracic Oncology, Aichi Cancer Center, 464-8681 - Nagoya/JP
  • 10Department Of Respiratory Medicine And Medical Oncology, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 11First Department Of Internal Medicine, Kansai Medical University, 573-1010 - Hirakata/JP
  • 12Department Of Thoracic Oncology, Hyogo Cancer Center, 673-0021 - Akashi/JP

Abstract

Background

Both CDDP+S-1 and CDDP+PEM could be given at full systemic doses with TRT in locally advanced NSCLC, and CDDP+PEM is one of the standard chemotherapy regimens in patients with advanced non-sq NSCLC. This multicenter, randomized, open-label, phase II study (SPECTRA) compared the efficacy and safety of the two above-mentioned promising regimens combined with TRT in patients with unresectable locally advanced non-sq NSCLC.

Methods

Patients were randomly assigned to receive CDDP+S-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDP+PEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. The sample size was set at 100 patients.

Results

Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDP+S-1 and 50 to CDDP+PEM. Baseline characteristics were similar (CDDP+S-1/CDDP+PEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n = 17 (33%)/n=17 (34%); stage IIIB, n = 21 (40%)/n=20 (40%); ECOG PS of 1, n = 14 (27%)/n=14 (28%); never smoker, n = 12 (23%)/n=12 (24%); and adenocarcinoma, n = 47(90%)/n=45(90%). Completion rate of TRT (60Gy) and chemotherapy (4 cycles) was 92%/98% and 73%/86%, respectively. Response rate was 60%/64%. Grade 3 toxicities included febrile neutropenia (12%/2%), anorexia (8%/16%), diarrhea (8%/0%), esophagitis (6%/8%), pneumonia (4%/4%), neutropenia (35%/50%), anemia (8%/12%), thrombocytopenia (4%/6%), and hyponatremia (12%/12%). Grade 2 radiation pneumonitis was observed in 8 (15%)/2 (4%) patients. No treatment-related death was observed. The data on PFS and overall survival is immature.

Conclusions

Response rate was similar between two arms. Toxicities were tolerable and manageable in both arms; however febrile neutropenia was more frequently observed in the CDDP+S-1 arm. Survival data will be analyzed in late 2018.

Clinical trial identification

UMIN000009914 (release date: 31/Jan/2013)

Legal entity responsible for the study

Yuichiro Ohe

Funding

Japan Agency for Medical Research and Development

Disclosure

S. Niho, T. Seto: Received honoraria from Taiho and Eli Lilly and research funding from Eli Lilly. K. Sakamaki, T. Yamanaka: Received honoraria from Taiho. T. Takahashi: Received research funding from Taiho and Eli Lilly and honoraria from Eli Lilly. M. Nishio, T. Hida, H. Okamoto, M. Satouchi, K. Goto, Y. Ohe: Received research funding and honoraria from Taiho and Eli Lilly. N. Yamamoto: Received research funding from Taiho. T. Kurata: Received research funding and honoraria from Eli Lilly. All other authors have declared no conflicts of interest.