A randomized controlled pilot study to compare capecitabine-oxaliplatin with 5-FU-leucovorin as neoadjuvant concurrent chemoradiation in locally advanced adenocarcinoma of rectum

Saha, Atanu; Ghosh, Santanu; Roy, Chhaya; Saha, Makhan; Choudhury, Krishnangshu Bhanja; Chatterjee, Koushik

doi:10.4103/0973-1482.150341

Cited by 12 publications

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“…Reviewers of the full-text articles revealed 9 articles that adequately match the inclusion and exclusion criteria, which contain short-term results and long-term results from 6 different clinical trials. [7,10,12,13,15,16,17–19] We also reviewed a total of 3652 ASCO abstracts about colorectal cancer in the last 4 years. Two abstracts matched the inclusion and exclusion criteria but were not published in other journals.…”

Section: Resultsmentioning

confidence: 99%

“…Study characterizes, including the time, country, study type, the number of patients, treatment, outcome, and Jadad score, are presented in Table 1. [12,13] The study outcomes included post-therapy pathology complete response (ypCR) rate, PFS, OS, Grade 3 to 4 adverse events (AEs), R0 resection rate, operation type, permanent stomas rate, postoperation complication, and postoperation death.…”

Section: Methodsmentioning

confidence: 99%

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Systematic review and meta-analysis of preoperative chemoradiotherapy with or without oxaliplatin in locally advanced rectal cancer

Zheng

Feng

et al. 2017

Medicine

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Background:Preoperative chemoradiotherapy has become the current standard regimen for locally advanced rectal cancer (LARC). However, the additional benefit of oxaliplatin to preoperative chemotherapy was still controversial. On one hand, oxaliplatin may improve the tumor response rate of even prolong the survival time. On the other hand, it can bring a series of adverse effects. Opinions vary from studies to studies. We aim to perform a meta-analysis to evaluate the efficacy, safety, and long-term survival of oxaliplatin in preoperative chemoradiotherapy for LARC.Method:To identify clinical trials fusing oxaliplatin in preoperative chemoradiotherapy for LARC published until December 2015, we searched PubMed, the Cochrane Library, and the Springer Link databases by combining various key words. We also search for relevant ASCO conferences. Data were extracted from every study to perform a meta-analysis using STATA 12.0 software.Result:Eleven articles or ASCO abstracts from 8 studies with a total of 5597 patients were included. Adding oxaliplatin to preoperative chemoradiotherapy can significantly improve the ypCR rate [risk ratio (RR) = 1.208, 95% confidence interval (95% CI): 1.070–1.364, P = 0.002, I2 = 14.5%], and decrease the preoperative metastasis (RR = 0.494, 95% CI: 0.256–0.954, P = 0.036, I2 = 53.9%) and local recurrence rate (RR = 0.761, 95% CI: 0.616–0.941, P = 0.012, I2 = 26.1%). What's more, oxaliplatin can prolong the disease-free survival (DFS) [hazard ratio (HR) = 0.867, 95% CI: 0.741–0.992, P = 0.000, I2 = 16.3%]. However, oxaliplatin can increase the chemoradiotherapy-related toxicities (RR = 1.858, 95% CI 1.427–2.419, P = 0.000, I2 = 84.7%). There was no significant difference between the groups with and without oxaliplatin in operation rate, R0 resection rate, sphincter preservation rate, permanent stoma rate, postoperative complication, mortality, and overall survival.Conclusion:Preoperative chemoradiotherapy with oxaliplatin bring both advantage and disadvantage to LARC. Whether to use oxaliplatin should be decided by patient's general condition and tolerance. Although oxaliplatin can prolong the DFS, survival benefit should be proved by further data.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Systematic review and meta-analysis of preoperative chemoradiotherapy with or without oxaliplatin in locally advanced rectal cancer

Zheng

Feng

et al. 2017

Medicine

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“…Saha et al noted Grade III haematological and genitourinary toxicity in 19% of the patients receiving FU/LV in preoperative chemoradiation. 18 Other Indian studies have noted similar excellent tolerance of Capecitabine in preoperative chemoradiation of rectal cancer. 16,17 Yerushalmi et al have published a retrospective study of their experience with Capecitabine and continuous Infusional 5-FU.…”

Section: Discussionmentioning

confidence: 75%

“…16,18 Patients in 5-FU arm: 8 out of 15 (53.3 %) and in CA arm: 9 out of 15 (60%), had partial response, 20% patients in 5-FU arm and 13.3% in CA arm had progression of disease, and 26.7 % patients in both the 5-FU and CA arms had stable disease. The difference was not statistically significant.…”

Section: Discussionmentioning

confidence: 97%

“…17 Saha et al have published their single center small pilot study comparing capecitabineoxaliplatin and 5-FU/LV in neoadjuvant chemoradiation of advanced rectal cancer. 18 In our institute this study was undertaken to compare local response and toxicity between continuous infusional 5-FU (5 days a week) and Capecitabine in the neoadjuvant chemoradiation of advanced rectal cancer. Fifteen patients were assigned to each chemo radiation arm.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of continuous infusional 5-fluorouracil and capecitabine in preoperative chemo radiotherapy for locally advanced rectal cancer: experience from a tertiary cancer centre from Southern India

et al. 2017

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Background: Neoadjuvant concurrent chemoradiation (CTRT) is the recommended treatment for locally advanced rectal cancer. 5 Fluorouracil (5-FU) has been the standard chemotherapy drug, but recent studies have proved Capecitabine (CA) is as effective as 5-FU in terms of local response, distant recurrences and overall survival except toxicities. We conducted this study to evaluate acute toxicities and local response rates between 5-FU and CA as neoadjuvant treatment modality combined with radiation.Methods: All patients with newly biopsy proven adenocarcinoma of rectum of TNM stage T3N0/ any T with N1,N2 and in whom curative treatment was planned with concurrent chemoradiation dose of 5040cGy in 28 fractions were included in the study. From January 2013 to June 2014, a total of thirty patients were enrolled in this study, fifteen patients received 5-FU (arm A) and fifteen patients received CA (arm B) during concurrent chemoradiation. All patients were evaluated for acute toxicities during treatment using RTOG criteria. Local response was assessed radiographically after four weeks of completion of CTRT utilising RECIST (Response Evaluation Criteria in Solid Tumors) criteria and also assessed for surgery simultaneously. Postoperatively adjuvant chemotherapy was considered in all patients.Results: Grade III toxicities were more in 5-FU arm compared to CA arm. The local response rates were almost same in both the arms, partial response in 5-FU and CA arm were 53.3% and 60% respectively.Conclusions: This is the first Indian study comparing Capecitabine and continuous Infusional 5FU in neoadjuvant CTRT of standard advanced rectal cancer patients. Oral Capecitabine had same efficacy when compared to 5-FU in terms of local response rates as neoadjuvant treatment modality in locally advanced rectal cancer, but CA was better tolerated with better patient compliance and was less toxic.

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Systematic review of treatment intensification using novel agents for chemoradiotherapy in rectal cancer

Clifford

Govindarajah

Parsons

et al. 2018

British Journal of Surgery

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BackgroundWith the well established shift to neoadjuvant treatment for locally advanced rectal cancer, there is increasing focus on the use of radiosensitizers to improve the efficacy and tolerability of radiotherapy. There currently exist few randomized data exploring novel radiosensitizers to improve response and it is unclear what the clinical endpoints of such trials should be.MethodsA qualitative systematic review was performed according to the PRISMA guidelines using preset search criteria across the PubMed, Cochrane and Scopus databases from 1990 to 2017. Additional results were generated from the reference lists of included papers.ResultsA total of 123 papers were identified, of which 37 were included; a further 60 articles were obtained from additional referencing to give a total of 97 articles. Neoadjuvant radiosensitization for locally advanced rectal cancer using fluoropyrimidine‐based chemotherapy remains the standard of treatment. The oral derivative capecitabine has practical advantages over 5‐fluorouracil, with equal efficacy, but the addition of a second chemotherapeutic agent has yet to show a consistent significant efficacy benefit in randomized clinical assessment. Preclinical and early‐phase trials are progressing with promising novel agents, such as small molecular inhibitors and nanoparticles.ConclusionDespite extensive research and promising preclinical studies, a definite further agent in addition to fluoropyrimidines that consistently improves response rate has yet to be found.

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A randomized controlled pilot study to compare capecitabine-oxaliplatin with 5-FU-leucovorin as neoadjuvant concurrent chemoradiation in locally advanced adenocarcinoma of rectum

Abstract: In terms of ORR, pCR rate, R0 resection, and toxicity profile; both the arms were comparable.

Cited by 12 publications

References 0 publications

Systematic review and meta-analysis of preoperative chemoradiotherapy with or without oxaliplatin in locally advanced rectal cancer

Systematic review and meta-analysis of preoperative chemoradiotherapy with or without oxaliplatin in locally advanced rectal cancer

Comparison of continuous infusional 5-fluorouracil and capecitabine in preoperative chemo radiotherapy for locally advanced rectal cancer: experience from a tertiary cancer centre from Southern India

Systematic review of treatment intensification using novel agents for chemoradiotherapy in rectal cancer

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