In Gyu Hwang1, Jun Ho Ji2, Jung Hun Kang3, Hyo Rak Lee4, Hui-Young Lee5, Kyong-Choun Chi6, Suk Won Park7, Su Jin Lee8, Seung Tae Kim8, Jeeyun Lee8, Se Hoon Park9, Joon Oh Park8, Young Suk Park8, Ho Yeong Lim8, Won Ki Kang8. 1. Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea. 2. Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea. 3. Gyeongsang National University, Jinju, Republic of Korea. 4. Korea Cancer Center Hospital, Seoul, Republic of Korea. 5. Kangwon National University School of Medicine, Chuncheon, Republic of Korea. 6. Department of Surgery, Chung-Ang University College of Medicine, Seoul, Republic of Korea. 7. Department of Radiation Oncology, Chung-Ang University College of Medicine, Seoul, Republic of Korea. 8. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 9. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: hematoma@skku.edu.
Abstract
OBJECTIVES: More than half of cases of gastric cancer (GC) are diagnosed in elderly patients (≥70years). While doublet combination with fluoropyrimidines and platinum is currently considered standard first-line chemotherapy in advanced GC, the main goal of chemotherapy remains palliation. MATERIALS AND METHODS: In a multi-center phase III trial, patients with chemotherapy-naïve, metastatic GC, aged 70years or older were randomized 1:1 to receive X monotherapy (capecitabine 1000mg/m2 bid po on days one to fourteen) or XELOX (X plus oxaliplatin 110mg/m2 iv on D1). Treatment was repeated every 21days until disease progression, unacceptable toxicity, or withdrawal. Primary endpoint was overall survival (OS). RESULTS: In total, 50 patients with a median age of 77 (range, 70 to 84) were enrolled (X, n=26; XELOX, n=24). No treatment-related serious adverse events or unexpected toxicities were observed. The most frequently observed toxicities were nausea and hand-foot syndrome, with fatigue and peripheral neuropathy more common in XELOX than in X patients. Median OS was 11.1months for XELOX arm and 6.3months for X arm (HR 0.58, 95% CI 0.30-1.12, P=0.108). Although the difference was not significant, on the basis of evidence of superiority of XELOX seen in the first interim analysis, an independent data monitoring committee recommended early stopping of the trial. PFS was significantly longer (HR 0.32, 95% CI 0.17-0.61, P<0.001) with XELOX (7.1months) than with X (2.6months). CONCLUSION:Platinum-based combination chemotherapy was associated with survival benefit, as compared with X monotherapy in elderly patients with GC.
RCT Entities:
OBJECTIVES: More than half of cases of gastric cancer (GC) are diagnosed in elderly patients (≥70years). While doublet combination with fluoropyrimidines and platinum is currently considered standard first-line chemotherapy in advanced GC, the main goal of chemotherapy remains palliation. MATERIALS AND METHODS: In a multi-center phase III trial, patients with chemotherapy-naïve, metastatic GC, aged 70years or older were randomized 1:1 to receive X monotherapy (capecitabine 1000mg/m2 bid po on days one to fourteen) or XELOX (X plus oxaliplatin 110mg/m2 iv on D1). Treatment was repeated every 21days until disease progression, unacceptable toxicity, or withdrawal. Primary endpoint was overall survival (OS). RESULTS: In total, 50 patients with a median age of 77 (range, 70 to 84) were enrolled (X, n=26; XELOX, n=24). No treatment-related serious adverse events or unexpected toxicities were observed. The most frequently observed toxicities were nausea and hand-foot syndrome, with fatigue and peripheral neuropathy more common in XELOX than in X patients. Median OS was 11.1months for XELOX arm and 6.3months for X arm (HR 0.58, 95% CI 0.30-1.12, P=0.108). Although the difference was not significant, on the basis of evidence of superiority of XELOX seen in the first interim analysis, an independent data monitoring committee recommended early stopping of the trial. PFS was significantly longer (HR 0.32, 95% CI 0.17-0.61, P<0.001) with XELOX (7.1months) than with X (2.6months). CONCLUSION:Platinum-based combination chemotherapy was associated with survival benefit, as compared with X monotherapy in elderly patients with GC.
Authors: Jin Won Kim; Jong Gwang Kim; Byung Woog Kang; Ik-Joo Chung; Young Seon Hong; Tae-You Kim; Hong Suk Song; Kyung Hee Lee; Dae Young Zang; Yoon Ho Ko; Eun-Kee Song; Jin Ho Baek; Dong-Hoe Koo; So Yeon Oh; Hana Cho; Keun-Wook Lee Journal: Cancer Res Treat Date: 2018-10-19 Impact factor: 4.679
Authors: Maeve A Hennessy; Munzir Hamid; Niamh M Keegan; Lynda Corrigan; Caitriona Goggin; Nay Myo Oo; Marie Carrigan; David Mockler; Anita O'Donovan; Anne M Horgan Journal: BMC Cancer Date: 2022-01-03 Impact factor: 4.430