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Poster display session

1998 - Safety data from randomized phase II study of cisplatin (CDDP)+S-1 versus CDDP+pemetrexed (PEM) combined with thoracic radiotherapy (TRT) for locally advanced non-squamous (non-sq) non-small cell lung cancer (NSCLC): SPECTRA study.


09 Sep 2017


Poster display session


Seiji Niho


Annals of Oncology (2017) 28 (suppl_5): v457-v459. 10.1093/annonc/mdx379


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

Author affiliations

  • 1 Department Of Thoracic Oncolgoy, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Department Of Thoracic Oncology, Aichi Cancer Center Hospital, 464-8681 - Aichi/JP
  • 3 Department Of Radiation Oncolgoy, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 4 Department Of Biostatistics, Yokohama City University School of Medicine, 236-0004 - Yokohama/JP
  • 5 Division Of Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 6 Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - FUKUOKA/JP
  • 7 Department Of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 135-8550 - Tokyo/JP
  • 8 Department Of Thoracic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 9 Department Of Thoracic Oncology, Aichi Cancer Center, 464-8681 - Nagoya/JP
  • 10 Department Of Respiratory Medicine And Medical Oncology, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 11 First Department Of Internal Medicine, Kansai Medical University, 573-1010 - Hirakata/JP
  • 12 Department Of Thoracic Oncology, Hyogo Cancer Center, 673-0021 - Akashi/JP


Abstract 1998


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.


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.


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.


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


Japan Agency for Medical Research and Development


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.

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