- Email: [email protected]
Lv in Elderly Patients with Metastatic Colorectal Cancer(J-Blue): Os Updated
Annals of Oncology 25 (Supplement 5): v44–v74, 2014 doi:10.1093/annonc/mdu435.113
Oral Session (Oral presentations categorized by each organ) O3
11
1
Toshiki Masuishi1,9, Mitsuo Shimada2, Tomohiro Nishina3, Toshikazu Moriwaki4, Mitsuharu Ozeki5, Yuji Negoro6, Shunju Indo7, Tadamichi Denda8, Takashi Maeba7, Ichinosuke Hyodo4 1 Department of Gastroenterology, Tsuchiura Kyodo General Hospital 2 Department of Surgery, The University of Tokushima 3 Division of Gastroenterology, National Hospital Organization Shikoku Cancer Center 4 Division of Gastroenterology, University of Tsukuba 5 Division of Gastroenterology, Ibaraki prefectural Central Hospital Cancer Center 6 Division of Gastroenterology, Kochi Health Sciences Center 7 Division of Surgery, Social Insurance Ritsurin Hospital 8 Division of Gastroenterology, Chiba Cancer Center 9 Department of Clinical Oncology, Aichi Cancer CenterHospital
abstracts
Background: The elderly patients ( pts) with metastatic colorectal cancer (mCRC) have been often left outside the clinical trials, and useful clinical data are limited. We showed
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v71/2240218 by guest on 25 October 2019
PHASE II STUDY OF BEVACIZUMAB PLUS UFT/LV IN ELDERLY PATIENTS WITH METASTATIC COLORECTAL CANCER(J-BLUE): OS UPDATED
that UFT/LV treatment for elderly pts was well-tolerated in the previous phase II study, and then evaluated the efficacy and safety of bevacizumab (Bmab) plus UFT/LV in the present study. Methods: This was an open-label, cooperative group (SGOSG-TCTG), phase II study (registered with UMIN000003515). Key eligibility criteria were age ≥ 75 years, ECOG performance status (PS) 0-1, no prior chemotherapy, at least one measurable lesion, and adequate organ functions. UFT at 300mg/m2/day and LV at 75mg/body/day were given for 3 weeks. Bmab was administered as an intravenous infusion at 5mg/kg on days 1 and 15. Treatment was repeated every 4 weeks. The primary endpoint was PFS (expected median PFS of 9 months with a threshold 4.5 months, one-sided α = 0.05, β = 0.1) and the secondary endpoints were response rate (RR), overall survival (OS) and safety. Results: Between Aug 2008 and Mar 2012, 55 pts were enrolled at 15 institutions. Of these, 52 pts were eligible and evaluated. Median age was 80 years (range: 75-87). ECOG PS 0 was 73%. Median PFS was 8.2 months (95% confidence interval [CI], 6.2-10, events in 92%). Confirmed RR was 40% (95%CI, 27-55), and disease control rate was 79% (95%CI, 65-89). Main reasons for treatment discontinuation were disease-progression (63%) and adverse events (AEs) (27%). Median OS was 24 months (95% CI, 13-34, events in 56% at data cutoff date of 30 Nov 2013). After the study treatment, 32 (62%) pts received oxaliplatin- or irinotecan-containing treatments. The most common grade ≥ 3 AEs were hypertension (12%), fatigue (8%), nausea (6%) and diarrhea (6%). No grade 3 hand-foot syndrome was observed. The treatment-related death occurred in 2 pts. Conclusion: Bmab plus UFT/LV was tolerable and effective in elderly pts with mCRC. Final OS data will be presented in the meeting.
Oral Session (Oral presentations categorized by each organ) O3
11
1
Toshiki Masuishi1,9, Mitsuo Shimada2, Tomohiro Nishina3, Toshikazu Moriwaki4, Mitsuharu Ozeki5, Yuji Negoro6, Shunju Indo7, Tadamichi Denda8, Takashi Maeba7, Ichinosuke Hyodo4 1 Department of Gastroenterology, Tsuchiura Kyodo General Hospital 2 Department of Surgery, The University of Tokushima 3 Division of Gastroenterology, National Hospital Organization Shikoku Cancer Center 4 Division of Gastroenterology, University of Tsukuba 5 Division of Gastroenterology, Ibaraki prefectural Central Hospital Cancer Center 6 Division of Gastroenterology, Kochi Health Sciences Center 7 Division of Surgery, Social Insurance Ritsurin Hospital 8 Division of Gastroenterology, Chiba Cancer Center 9 Department of Clinical Oncology, Aichi Cancer CenterHospital
abstracts
Background: The elderly patients ( pts) with metastatic colorectal cancer (mCRC) have been often left outside the clinical trials, and useful clinical data are limited. We showed
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v71/2240218 by guest on 25 October 2019
PHASE II STUDY OF BEVACIZUMAB PLUS UFT/LV IN ELDERLY PATIENTS WITH METASTATIC COLORECTAL CANCER(J-BLUE): OS UPDATED
that UFT/LV treatment for elderly pts was well-tolerated in the previous phase II study, and then evaluated the efficacy and safety of bevacizumab (Bmab) plus UFT/LV in the present study. Methods: This was an open-label, cooperative group (SGOSG-TCTG), phase II study (registered with UMIN000003515). Key eligibility criteria were age ≥ 75 years, ECOG performance status (PS) 0-1, no prior chemotherapy, at least one measurable lesion, and adequate organ functions. UFT at 300mg/m2/day and LV at 75mg/body/day were given for 3 weeks. Bmab was administered as an intravenous infusion at 5mg/kg on days 1 and 15. Treatment was repeated every 4 weeks. The primary endpoint was PFS (expected median PFS of 9 months with a threshold 4.5 months, one-sided α = 0.05, β = 0.1) and the secondary endpoints were response rate (RR), overall survival (OS) and safety. Results: Between Aug 2008 and Mar 2012, 55 pts were enrolled at 15 institutions. Of these, 52 pts were eligible and evaluated. Median age was 80 years (range: 75-87). ECOG PS 0 was 73%. Median PFS was 8.2 months (95% confidence interval [CI], 6.2-10, events in 92%). Confirmed RR was 40% (95%CI, 27-55), and disease control rate was 79% (95%CI, 65-89). Main reasons for treatment discontinuation were disease-progression (63%) and adverse events (AEs) (27%). Median OS was 24 months (95% CI, 13-34, events in 56% at data cutoff date of 30 Nov 2013). After the study treatment, 32 (62%) pts received oxaliplatin- or irinotecan-containing treatments. The most common grade ≥ 3 AEs were hypertension (12%), fatigue (8%), nausea (6%) and diarrhea (6%). No grade 3 hand-foot syndrome was observed. The treatment-related death occurred in 2 pts. Conclusion: Bmab plus UFT/LV was tolerable and effective in elderly pts with mCRC. Final OS data will be presented in the meeting.