Initial Safety Analysis of CapeOx for Elderly Patients With Advanced Gastric Cancer Patients: A Phase II Trial

Chin, Keisho; Takahari, Daisuke; Kawabata, Ryohei; Hosaka, Hisashi; Saitou, S O; Shiraishi, Takeshi; Yabusaki, Hiroshi; Goto, Masahiro; Nakamura, Masato; Imamura, Hiroshi; Shindo, Yoshiaki; Nagashima, Fumio; Ichikawa, Wataru; Saotome, Takashi; Yamamoto, Wataru; Ishizuka, Naoki; Yamaguchi, Kensei

doi:10.21873/anticanres.15746

Cited by 3 publications

(3 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Compared with oxaliplatin, docetaxel has some advantages in tolerability, such as cumulative peripheral neurotoxicity, gastrointestinal toxicity, which may seriously affect patients' quality of life, and thrombocytopenia. The occurrence of any grade and grade ≥ 3 peripheral neuropathy (19% and 0%), nausea (19% and 3%), vomiting (3% and 0%), and thrombocytopenia (29% and 0%) in the current study suggests that those toxicities were moderate compared with platinum doublet regimens [17], possibly because of the use of docetaxel. Our data thus suggest that DS regimens could be suitable alternatives for older patients who may have di culty continuing chemotherapy due to peripheral neuropathy and gastrointestinal toxicity.…”

Section: Discussionmentioning

confidence: 56%

“…Recently, the results of several trials of uorouracil combined with oxaliplatin chemotherapy for frail or older patients with advanced gastroesophageal cancer were published. A phase II trial of CapeOx for 20 older patients with advanced gastric cancer showed that 9 of 19 patients (47%) who could undergo a second course needed a dose reduction, 8 of 19 patients (42%) needed a course delay, and 5 of 20 patients (25%) were unable to complete the initial two courses of chemotherapy due to withdrawal, AEs, or progressive disease [17]. Indeed, relatively high toxicities (any grade and grade ≥ 3) were reported for peripheral neuropathy (60% and 0%), nausea (55% and 10%), vomiting (10% and 0%), and thrombocytopenia (55% and 0%), respectively [17].…”

Section: Discussionmentioning

confidence: 99%

“…A phase II trial of CapeOx for 20 older patients with advanced gastric cancer showed that 9 of 19 patients (47%) who could undergo a second course needed a dose reduction, 8 of 19 patients (42%) needed a course delay, and 5 of 20 patients (25%) were unable to complete the initial two courses of chemotherapy due to withdrawal, AEs, or progressive disease [17]. Indeed, relatively high toxicities (any grade and grade ≥ 3) were reported for peripheral neuropathy (60% and 0%), nausea (55% and 10%), vomiting (10% and 0%), and thrombocytopenia (55% and 0%), respectively [17]. The GO2 phase III trial of CapeOX for frail or older patients comparing three doses of CapeOX (100%, 80%, and 60%) concluded that PFS for the reduced-dose groups compared with the full-dose group as the primary endpoint showed non-inferiority [18].…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

Kawase,

Imamura,

Kawabata

et al. 2024

Int J Clin Oncol

Self Cite

View full text Add to dashboard Cite

BackgroundAlthough there is insu cient evidence for the treatment of older patients with advanced gastric cancer, uorouracil combined with platinum chemotherapy has been recognized as a standard rst-line treatment for such populations in Japan despite the lack of e cacy and toxicity data. MethodsPatients aged 75 years or older with advanced gastric cancer were enrolled. S-1 plus docetaxel (docetaxel: 40 mg/m 2 , day 1; S-1: 80 mg/m 2 , days 1-14; q21 days) was repeated every 3 weeks. The primary endpoint was overall response rate. Secondary endpoints were safety, progression-free survival, time to treatment failure, and overall survival. The sample size was calculated as 30 under the hypothesis of an expected response rate of 40% and a threshold response rate of 20%, at a power of 90% and a twosided alpha value of 5%. ResultsFrom February 2010 to January 2015, 31 patients were enrolled and assessed for e cacy and toxicity.The response rate was 45.2% (95% CI: 27.3-64.0%; p = 0.001) and it exceeded the expected response rate set at 40%. Median progression-free survival was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1 months. The major grade 3/4 adverse events were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%). ConclusionsThese ndings indicate that S-1 plus docetaxel as rst-line treatment for older patients is feasible and that it has promising e cacy against advanced gastric cancer.

show abstract

Section: Discussionmentioning

confidence: 56%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

Kawase,

Imamura,

Kawabata

et al. 2024

Int J Clin Oncol

Self Cite

View full text Add to dashboard Cite

show abstract

Multicenter phase II study of capecitabine plus oxaliplatin in older patients with advanced gastric cancer: the Tokyo Cooperative Oncology Group (TCOG) GI-1601 study

Kawabata,

Chin,

Takahari

et al. 2023

Gastric Cancer

View full text Add to dashboard Cite

Background Capecitabine plus oxaliplatin (CapeOX) is a standard treatment option for advanced gastric cancer (AGC). We conducted a prospective multicenter phase II study to evaluate the efficacy and safety of CapeOX as a first-line therapy for AGC in older patients. Methods Chemotherapy-naive patients aged ≥ 70 years with AGC were eligible. Initial treatment comprised capecitabine (2000 mg/m2 on days 1–14) and oxaliplatin (130 mg/m2 on day 1) every 3 weeks. After the initial feasibility assessment, the dose was reduced considering toxicity (capecitabine, 1500 mg/m2 on days 1–14; and oxaliplatin, 100 mg/m2 on day 1 every 3 weeks). The primary endpoint was overall survival (OS). Results In total, 108 patients were enrolled, of whom 104 were evaluated. Thirty-nine patients received the original-dose treatment, whereas 65 received the reduced-dose treatment. The median OS, progression-free survival (PFS), and time to treatment failure (TTF) were 12.9 (95% CI 11.6–14.8), 5.7 (95% CI 5.0–7.0), and 4.3 (95% CI 3.9–5.7) months, respectively, for all patients; 13.4 (95% CI 9.5–16.0), 5.8 (95% CI 4.1–7.8), and 5.3 (95% CI 3.5–7.2) months in the original-dose group; and 12.8 (95% CI 11.3–15.3), 5.7 (95% CI 4.4–7.0), and 4.1 (95% CI 3.7–5.7) months in the reduced-dose group. The most common grade 3/4 toxicities were neutropenia (17.9%), anemia (12.8%), and thrombocytopenia (12.8%) in the original-dose group and neutropenia (13.8%) and anorexia (12.3%) in the reduced-dose group. Conclusions These findings demonstrate CapeOX's efficacy and safety in older AGC patients.

show abstract

Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

Kawase

Imamura

Kawabata

et al. 2023

Preprint

Self Cite

View full text Add to dashboard Cite

Background Although there is insufficient evidence for the treatment of older patients with advanced gastric cancer, fluorouracil combined with platinum chemotherapy has been recognized as a standard first-line treatment for such populations in Japan despite the lack of efficacy and toxicity data. Methods Patients aged 75 years or older with advanced gastric cancer were enrolled. S-1 plus docetaxel (docetaxel: 40 mg/m2, day 1; S-1: 80 mg/m2, days 1–14; q21 days) was repeated every 3 weeks. The primary endpoint was overall response rate. Secondary endpoints were safety, progression-free survival, time to treatment failure, and overall survival. The sample size was calculated as 30 under the hypothesis of an expected response rate of 40% and a threshold response rate of 20%, at a power of 90% and a two-sided alpha value of 5%. Results From February 2010 to January 2015, 31 patients were enrolled and assessed for efficacy and toxicity. The response rate was 45.2% (95% CI: 27.3–64.0%; p = 0.001) and it exceeded the expected response rate set at 40%. Median progression-free survival was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1 months. The major grade 3/4 adverse events were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%). Conclusions These findings indicate that S-1 plus docetaxel as first-line treatment for older patients is feasible and that it has promising efficacy against advanced gastric cancer.

show abstract

Initial Safety Analysis of CapeOx for Elderly Patients With Advanced Gastric Cancer Patients: A Phase II Trial

Cited by 3 publications

References 0 publications

Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

Multicenter phase II study of capecitabine plus oxaliplatin in older patients with advanced gastric cancer: the Tokyo Cooperative Oncology Group (TCOG) GI-1601 study

Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

Contact Info

Product

Resources

About