Uracil-Tegafur and Oral Leucovorin Combined With Bevacizumab in Elderly Patients (Aged ≥ 75 Years) With Metastatic Colorectal Cancer: A Multicenter, Phase II Trial (Joint Study of Bevacizumab, Oral Leucovorin, and Uracil-Tegafur in Elderly Patients [J-BLUE] Study)

Nishina, Tomohiro; Moriwaki, Toshikazu; Shimada, Mitsuo; Higashijima, Jun; Sakai, Yoshinori; Masuishi, Toshiki; Ozeki, Mitsuharu; Amagai, Kenji; Negoro, Yuji; Indo, Shunju; Denda, Tadamichi; Sato, Mikio; Yamamoto, Yuji; Nakajima, Go; Mizuta, Minoru; Takahashi, Ikuo; Hiroshima, Yoshinori; Ishida, Hiroyasu; Mizutani, Takashi; Hyodo, Ichinosuke

doi:10.1016/j.clcc.2015.12.001

Cited by 14 publications

(16 citation statements)

References 20 publications

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“…In the BASIC trial, the incidence of grade 3 or more toxicities was observed in less than 10% patients; however, 36% of the patients discontinued treatment due to toxicities [11]. Similar results were observed in a phase II study of uracil-tegafur plus oral leucovorin combined with bevacizumab in elderly patients with mCRC (grade 3 or more toxicities in less than 10% patients and discontinuation of study treatment due to any of the toxicities in 25% patients) [19]. A novel FP-containing regimen that is better tolerated should be developed for the elderly patients.…”

Section: Discussionsupporting

confidence: 66%

Rationale and Study Protocol of the J-SAVER Study: A Phase II Study of S-1 on Alternate Days Combined with Bevacizumab in Patients Aged ≥75 Years with Metastatic Colorectal Cancer

Moriwaki¹,

Eto²,

Tsuji³

et al. 2017

JCT

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Fluoropyrimidine combined with bevacizumab is commonly used in elderly patients with metastatic colorectal cancer worldwide. However, the proportion of elderly patients who discontinued treatment due to toxicities was higher than that of younger patients. The aim of this study is to develop a less toxic schedule of S-1, while maintaining the anti-tumor effect. This phase II study is aimed to evaluate an alternate-day administration of S-1 combined with bevacizumab in untreated elderly patients (aged ≥75 years) with metastatic colorectal cancer. The primary endpoint is progression-free survival, and the secondary endpoints are safety, response rate, and overall survival. The expected median progression-free survival is 8.5 months, and the minimum efficacy threshold is 5.0 months. The total required sample size is calculated as 50 patients, with a 2-sided type I error of 0.10 and a power of more than 80%. This study is ongoing, and fifty-four patients were enrolled until October 2016. We hope that S-1 on alter-

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Section: Discussionsupporting

confidence: 66%

Rationale and Study Protocol of the J-SAVER Study: A Phase II Study of S-1 on Alternate Days Combined with Bevacizumab in Patients Aged ≥75 Years with Metastatic Colorectal Cancer

Moriwaki¹,

Eto²,

Tsuji³

et al. 2017

JCT

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“…Patients with a median age of 76–77 years gained a 4-month PFS benefit (HR: 0.53, 95% CI: 0.41–0.69; p < 0.001) and a clinically, but not statistically, significant OS benefit of 3.9 months (HR: 0.79, 95% CI: 0.57–1.09; p = 0.182) with bevacizumab plus capecitabine versus capecitabine alone [ 7 ]. Recently, data from a single-arm Japanese phase 2 trial, including 55 patients with mCRC, were published, demonstrating that the oral fluoropyrimidine UFT combined with biweekly bevacizumab is a tolerable and effective treatment option for elderly patients [ 9 ]. Similarly, a pooled analysis of four randomised clinical studies comparing elderly with younger mCRC patients showed that the addition of bevacizumab to chemotherapy provided comparable PFS and OS benefits in medically fit older patients [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

“…Apart from AVEX, no further randomized studies addressing this sometimes more fragile population are available. Besides, some small cohort or single-arm studies enrolling elderly patients suggested that these patients also benefit from the addition of bevacizumab to standard chemotherapy [ 8 , 9 ]. Meta-analysis of a number of similar clinical trials is an option to allow analysis of a sufficient amount of clinical data.…”

Section: Introductionmentioning

confidence: 99%

Bevacizumab-based first-line chemotherapy in elderly patients with metastatic colorectal cancer: an individual patient data based meta-analysis

Koch¹,

Schwing²,

Herrmann

et al. 2017

Oncotarget

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BackgroundThe aim of this meta-analysis was to evaluate efficacy and safety of first-line chemotherapy with or without a monoclonal antibody in elderly patients (≥ 70 years) with metastatic colorectal cancer (mCRC), since they are frequently underrepresented in clinical trials.ResultsIndividual data from 10 studies were included. From a total of 3271 patients, 604 patients (18%) were ≥ 70 years (median 73 years, range 70–88). Of these, 335 patients were treated with a bevacizumab-based first-line regimen and 265 were treated with chemotherapy only. The median PFS was 8.2 vs. 6.5 months and the median OS was 16.7 vs. 13.0 months in patients treated with and without bevacizumab, respectively. The safety profile of bevacizumab in combination with first-line chemotherapy did not differ from published clinical trials.Materials and MethodsPubMed and Cochrane Library searches were performed on 29 April 2013 and studies published to this date were included. Authors were contacted to request progression-free survival (PFS), overall survival (OS) data, patient data on treatment regimens, age, sex and potential signs of toxicity in patients ≥ 70 years of age.ConclusionsThis meta-analysis suggests that the addition of bevacizumab to standard first-line chemotherapy improves clinical outcome in elderly patients with mCRC and is well tolerated.

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“…Response rate was 40%, mPFS was 8.2 months and mOS 23 months, and more than half (65%) of patients continued with second-line therapy. 25 …”

Section: Treatment Of Older or Frail Patients With Mcrcmentioning

confidence: 99%

Can we predict toxicity and efficacy in older patients with cancer? Older patients with colorectal cancer as an example

et al. 2016

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Colorectal cancer is a disease of the elderly. As older and frail patients are under-represented in clinical trials, most of the evidence available on treatment of older metastatic colorectal patients with cancer originates from pooled analyses of the older patients included in large prospective clinical trials and from community-based studies. The aging process is highly individual and cannot be based on the chronological age alone. It is characterised by a decline in organ function with an increased risk of comorbidity and polypharmacy. These issues can result in an increased susceptibility to the complications of both the disease and treatment. Therefore, evaluation of performance status and the chronological age alone is not sufficient, and additionally assessment must be included in the treatment decision process. In the present review, we will focus on clinical aspects of treating older and frail metastatic colorectal patients with cancer, but also on the present knowledge on how to select and tailor therapy for this particular group of patients.Trial registration numberEudraCT 2014-000394-39, pre-results.

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Uracil-Tegafur and Oral Leucovorin Combined With Bevacizumab in Elderly Patients (Aged ≥ 75 Years) With Metastatic Colorectal Cancer: A Multicenter, Phase II Trial (Joint Study of Bevacizumab, Oral Leucovorin, and Uracil-Tegafur in Elderly Patients [J-BLUE] Study)

Cited by 14 publications

References 20 publications

Rationale and Study Protocol of the J-SAVER Study: A Phase II Study of S-1 on Alternate Days Combined with Bevacizumab in Patients Aged ≥75 Years with Metastatic Colorectal Cancer

Rationale and Study Protocol of the J-SAVER Study: A Phase II Study of S-1 on Alternate Days Combined with Bevacizumab in Patients Aged ≥75 Years with Metastatic Colorectal Cancer

Bevacizumab-based first-line chemotherapy in elderly patients with metastatic colorectal cancer: an individual patient data based meta-analysis

Can we predict toxicity and efficacy in older patients with cancer? Older patients with colorectal cancer as an example

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