- Email: [email protected]
Final Result of Randomized Phase 2 Trial Comparing Amrubicin (A) with Re-Challenge of Platinum Doublet (P) in Patients (Pts) with Sensitive-Relapsed Small-Cell Lung Cancer (Sclc): Njlcg0702
Annals of Oncology 25 (Supplement 4): iv511–iv516, 2014 doi:10.1093/annonc/mdu355.9
SCLC 1471P
abstracts
M. Maemondo1, A. Inoue2, S. Sugawara3, Y. Mori4, S. Oizumi5, M. Harada6, K. Taima7, N. Morikawa8, T. Ishida9, I. Kinoshita10, H. Watanabe11, T. Suzuki4, T. Nakagawa12, R. Saito2, T. Nukiwa13 1 Respiratory Medicine, Miyagi Cancer Center, Natori, JAPAN 2 Department of Respiratory Medicine, Tohoku University, Sendai, JAPAN 3 Department of Respiratory Medicine, Sendai Kousei Hospital, Sendai, JAPAN 4 Division of Respiratory Medicine, Iwate Prefectural Central Hospital, Morioka, JAPAN 5 First Department of Medicine, Hokkaido University School of Medicine, Sapporo, JAPAN 6 Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center, Sapporo, JAPAN 7 Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, JAPAN 8 Pulmonary Medicine,Allergy And Rheumatology, Iwate Medical University School Of Medicine, Iwate, JAPAN 9 Clinical Oncology Center, Fukushima Medical University, Fukushima, JAPAN 10 Department of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo, JAPAN 11 Respiratory Medicine, Saka Genaral Hospital, Shiogama, JAPAN 12 Thoracic Surgery, Omagari-Kosei Medical Center, Omagari, JAPAN 13 South Miyagi Medical Center, Miyagi, JAPAN
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv514/2242173 by guest on 25 October 2019
FINAL RESULT OF RANDOMIZED PHASE 2 TRIAL COMPARING AMRUBICIN (A) WITH RE-CHALLENGE OF PLATINUM DOUBLET (P) IN PATIENTS (PTS) WITH SENSITIVE-RELAPSED SMALL-CELL LUNG CANCER (SCLC): NJLCG0702
Aim: When this trial was planned, A was believed to be a promising new anthracycline agent for sensitive-relapsed SCLC. While re-challenge of P that had been used for the first-line treatment was also believed to be effetive for sensitive-relapsed SCLC, although prospective evaluation of it had not been reported. Thus this randomized phase 2 study was conducted to select A or P for future phase 3 trial. Methods: Sensitive-ralapsed SCLC pts were randomized to receive A (40mg/m2, day1-3, every 3 weeks) or P (every 3-4 weeks). The modification of P such as the 20%-dose reduction of combined third-generation or change of platinum agent from cisplatin to carboplatin according to patient’s condition was permitted. The primary endpoint was overall response rate (ORR), and secondary endpoint were progression-free survival (PFS), overall survival (OS), and toxicity profile. According to the Simon’s two-stage phase 2 design, 28 pts were required in each arm ( p0=0.3, p1=0.5, alpha=0.01, beta=0.02), and the treatment that achieved not less 12 out of 28 pts with partial response would be judged as effective. Results: From February 2008 to June 2013, 60 pts were enrolled from 14 institutions. Two patients in the A arm and one patient in the P arm did not receive any protocol treatment due to rapid disease progression. Evaluated patients’ characteristics were as follows: Male/Female, 53/4; median age, 66 (range 44-80); performance status 0/1/2, 32/21/4. The median number of treatment cycles was 4 (range 2-8) in A arm and 3 (range 1-7) in P arm. ORRs and disease control rates were 67% (95%CI, 50-84) and 86% for A, and 43% (95%CI, 25-61) and 80% for P, respectively. Mdian PFS and OS were 5.4 months and 14.4 months in A arm, and 5.1 months and 14.3 months in P arm. Grade 3 toxicity was observed in 33% of patients in A arm including 19% of febrile neutorpenia, while 17% in P arm without any febrile neutropenia. There was no grade 4 toxicity or treatment-related death in this trial. Conclusions: Both treatments met the primary endpoint. Since A produced higher ORR and longer median PFS than P with acceptable toxicity, we select A for subsequent phase 3 trial. Disclosure: All authors have declared no conflicts of interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
SCLC 1471P
abstracts
M. Maemondo1, A. Inoue2, S. Sugawara3, Y. Mori4, S. Oizumi5, M. Harada6, K. Taima7, N. Morikawa8, T. Ishida9, I. Kinoshita10, H. Watanabe11, T. Suzuki4, T. Nakagawa12, R. Saito2, T. Nukiwa13 1 Respiratory Medicine, Miyagi Cancer Center, Natori, JAPAN 2 Department of Respiratory Medicine, Tohoku University, Sendai, JAPAN 3 Department of Respiratory Medicine, Sendai Kousei Hospital, Sendai, JAPAN 4 Division of Respiratory Medicine, Iwate Prefectural Central Hospital, Morioka, JAPAN 5 First Department of Medicine, Hokkaido University School of Medicine, Sapporo, JAPAN 6 Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center, Sapporo, JAPAN 7 Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, JAPAN 8 Pulmonary Medicine,Allergy And Rheumatology, Iwate Medical University School Of Medicine, Iwate, JAPAN 9 Clinical Oncology Center, Fukushima Medical University, Fukushima, JAPAN 10 Department of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo, JAPAN 11 Respiratory Medicine, Saka Genaral Hospital, Shiogama, JAPAN 12 Thoracic Surgery, Omagari-Kosei Medical Center, Omagari, JAPAN 13 South Miyagi Medical Center, Miyagi, JAPAN
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv514/2242173 by guest on 25 October 2019
FINAL RESULT OF RANDOMIZED PHASE 2 TRIAL COMPARING AMRUBICIN (A) WITH RE-CHALLENGE OF PLATINUM DOUBLET (P) IN PATIENTS (PTS) WITH SENSITIVE-RELAPSED SMALL-CELL LUNG CANCER (SCLC): NJLCG0702
Aim: When this trial was planned, A was believed to be a promising new anthracycline agent for sensitive-relapsed SCLC. While re-challenge of P that had been used for the first-line treatment was also believed to be effetive for sensitive-relapsed SCLC, although prospective evaluation of it had not been reported. Thus this randomized phase 2 study was conducted to select A or P for future phase 3 trial. Methods: Sensitive-ralapsed SCLC pts were randomized to receive A (40mg/m2, day1-3, every 3 weeks) or P (every 3-4 weeks). The modification of P such as the 20%-dose reduction of combined third-generation or change of platinum agent from cisplatin to carboplatin according to patient’s condition was permitted. The primary endpoint was overall response rate (ORR), and secondary endpoint were progression-free survival (PFS), overall survival (OS), and toxicity profile. According to the Simon’s two-stage phase 2 design, 28 pts were required in each arm ( p0=0.3, p1=0.5, alpha=0.01, beta=0.02), and the treatment that achieved not less 12 out of 28 pts with partial response would be judged as effective. Results: From February 2008 to June 2013, 60 pts were enrolled from 14 institutions. Two patients in the A arm and one patient in the P arm did not receive any protocol treatment due to rapid disease progression. Evaluated patients’ characteristics were as follows: Male/Female, 53/4; median age, 66 (range 44-80); performance status 0/1/2, 32/21/4. The median number of treatment cycles was 4 (range 2-8) in A arm and 3 (range 1-7) in P arm. ORRs and disease control rates were 67% (95%CI, 50-84) and 86% for A, and 43% (95%CI, 25-61) and 80% for P, respectively. Mdian PFS and OS were 5.4 months and 14.4 months in A arm, and 5.1 months and 14.3 months in P arm. Grade 3 toxicity was observed in 33% of patients in A arm including 19% of febrile neutorpenia, while 17% in P arm without any febrile neutropenia. There was no grade 4 toxicity or treatment-related death in this trial. Conclusions: Both treatments met the primary endpoint. Since A produced higher ORR and longer median PFS than P with acceptable toxicity, we select A for subsequent phase 3 trial. Disclosure: All authors have declared no conflicts of interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].