Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

Ryu, Sang Baek; Lee, Won-Moo; Kim, Kidong; Park, Sang-Il; Kim, Beob-Jong; Kim, Moon-Hong; Choi, Seok-Cheol; Cho, Chul-Koo; Nam, Byung–Ho; Lee, Eui-Don

doi:10.1016/j.ijrobp.2011.05.002

Cited by 69 publications

(67 citation statements)

References 15 publications

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“…The high peak concentration of cisplatin may be more effective not only in enhancing the synergy of chemoradiation but also in eliminating micrometastases, with resulting decrease of local failure and distant metastasis and improvement of survival eventually with a tolerable toxicity profile [9,10]. Similar studies conducted earlier Ryu et al on 104 patients with histologically proven Stage IIB-IVA cervical cancer concluded that there was no statistically significant difference in compliance between the two arms.…”

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confidence: 72%

“…Grade 3-4 neutropenia was more frequent in the weekly arm than in the three weekly arm. The overall 5-year survival rate was significantly higher in the three weekly arm than in the weekly arm [10]. Another trial conducted by Nagy et al on 326 patients with locally advanced squamous cell cervical carcinoma concluded that the 5-year survival rate obtained through the 2 RCT regimens are not statistically different [11].…”

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confidence: 94%

“…A possible hypothesis of this study is that the higher peak concentration of cisplatin may be more critical in enhancing synergy of chemoradiation than the weekly cisplatin exposure [8,9]. The high peak concentration of cisplatin may be more effective not only in enhancing the synergy of chemoradiation but also in eliminating micrometastases, with resulting decrease of local failure and distant metastasis and improvement of survival eventually with a tolerable toxicity profile [10,11].…”

Section: Introductionmentioning

confidence: 91%

“…This study was planned with the view is that the higher peak concentration of cisplatin may be more critical in enhancing synergy of chemoradiation than the weekly cisplatin exposure. Although the dose-response slope of cisplatin is not steep, the response of tumor to cisplatin has been shown to increase as the peak concentration of cisplatin increases up to 100 mg/m 2 [9,10].…”

Section: { {mentioning

confidence: 99%

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Comparing Weekly versus Three Weekly Schedules of Cisplatinum Concomitant with Radical Radiotherapy in Locally Advanced Carcinoma Uterine Cervix

Mittal¹,

Chauhan²,

Kaur³

et al. 2017

Gynecol Obstet

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Aims and 0bjectives: To determine and evaluate the difference/s, in terms of tumor control and side effects, between weekly and three weekly cisplatin concomitant with radical course of radiotherapy for locally advanced carcinoma of cervix. Materials and methods:The study was conducted on sixty previously untreated, histopathologically proven patients of locally advanced carcinoma of uterine cervix. The patients were treated with External Beam Radiotherapy (EBRT) 50Gy in 25 fractions over 5 weeks and concomitant cisplatin, followed by intra-cavity HDR brachytherapy (ICBT) 700cGy to point A, once in a week for three weeks. The patients were assigned randomly either of two groups of 30 patients each. In Group I (Study Group) the patients received three weekly cisplatin 75 mg/m 2 for 2 cycles while in Group II (Control Group) the patients received weekly cisplatin 40 mg/m 2 for 5 cycles. Evaluation of response and toxicity was done weekly during treatment and monthly thereafter. The data thus obtained was assessed and analysed using SPSS version 20.0 statistical tool.

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Section: { {mentioning

confidence: 72%

Section: { {mentioning

confidence: 94%

Section: Introductionmentioning

confidence: 91%

Section: { {mentioning

confidence: 99%

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Comparing Weekly versus Three Weekly Schedules of Cisplatinum Concomitant with Radical Radiotherapy in Locally Advanced Carcinoma Uterine Cervix

Mittal¹,

Chauhan²,

Kaur³

et al. 2017

Gynecol Obstet

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“…However, the survival benefit of these modified regimens remains unclear, despite their ability to alleviate toxicities and improve treatment compliance. Split-or low-dose cisplatin regimens have also been investigated in treatment of other cancers for their efficacy and safety [20][21][22][23][24]. However, in most of these studies, no clinical benefit of a modified dose and schedule of cisplatin has been demonstrated compared with high-to moderatedose cisplatin schedules.…”

Section: Discussionmentioning

confidence: 99%

A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer

et al. 2013

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Background S-1 plus weekly split-dose cisplatin demonstrated promising results in previous phase I and II studies for advanced gastric cancer (AGC) patients. Methods In this randomized phase II study, the efficacy and safety of S-1 plus weekly split-dose cisplatin (SWP, S-1 daily oral dose of 80-120 mg according to body surface area on days 1-14, and cisplatin 20 mg/m 2 i.v. on days 1 and 8 every 3 weeks) were compared with those of S-1 plus standard-dose cisplatin (SP) as first-line chemotherapy for AGC patients. The primary endpoint was 1-year survival rate.Results Patients were randomized into two groups: 18 in the SWP arm and 19 in the SP arm. This trial was terminated early because of low patient enrollment. The 1-year survival rate was 61 % [95 % confidence interval (CI), 36-86 %] and 53 % (95 % CI, 30-75 %) in the SWP and SP arms, respectively. However, the median survival time was 12.3 months (9.9-14.6 months) and 15.7 months (4.0-27.4 months), respectively (P = 0.064). Progressionfree survival was significantly shorter in the SWP arm than in the SP arm (P = 0.047). Toxicity tended to be milder in the SWP arm than in the SP arm. For approximately 40 % of patients in the SWP arm, cisplatin was omitted on day 8 and treatment delayed because of prolonged myelosuppression. Conclusions No clear benefits of adding cisplatin to S-1 in the SWP arm were demonstrated in this study. At this point, split-dose cisplatin combined with S-1 cannot be recommended for use in clinical practice.

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Concurrent Chemoradiotherapy for Stage IIIB Cervical Cancer—Global Impact Through Power

2018

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Of the 500 000 new cervical cancer cases annually, most (85%) locally advanced cervical cancer (LACC) occurs in low-and middle-income countries (LMICs), where sufficient resources are not always readily available for treatment. 1 For almost 2 decades, the optimal management for all LACC in the United States has included concurrent chemoradiotherapy (CRT). A National Cancer Institute 2 alert was released in 1999, after the publication of multiple randomized clinical trials demonstrated improved survival rates with concurrent CRT compared with radiotherapy (RT) alone. In particular, the Radiation Therapy Oncology Group (RTOG) 90-01 trial 3 showed a 5-year absolute survival benefit of 21% for all stages of cervical cancer with CRT. However, an unplanned and inadequately powered subgroup analysis of patients with stage III to IVA disease showed an overall survival (OS) advantage of 14% (P = .06), disease-free survival (DFS) benefit of 17% (P = .05), and locoregional control benefit of 15% (P = .065). 3 A 2010 meta-analysis 4 demonstrated a 5-year absolute OS benefit of 6% for all stages of cervical cancer treated with concurrent CRT compared with RT alone; however, the survival benefit was only 3% for women with stage III to IVA cervical cancer. Nevertheless, due to the lack of statistical significance in the patient subgroup with stage IIIB to IVA disease in RTOG 90-01, combined with issues of cost and access, some LMICs chose not to standardize CRT for all patients with LACC.The importance of statistical power (ie, having sufficient number of patients to show a benefit) is clearly demonstrated in the trial by Shrivastava et al 5 in this issue of JAMA Oncology. Their study is remarkable because it addresses this important global clinical dilemma and provides sufficient power in a subgroup of patients. This not only is one of the largest studies on LACC overall but also is the only study with sufficient numbers of patients to report conclusive randomized trial evidence for CRT in the stage IIIB subgroup. The study, conducted in Mumbai, India, at Tata Memorial Hospital, a high-volume government-directed cancer treatment institution, randomized women to receive external beam RT (50 Gy in 25 fractions) with brachytherapy alone or in combination with weekly cisplatin chemotherapy (40 mg/m 2 ). The trial results show detailed patient information, good treatment compliance, and reasonable long-term follow-up. The authors were able to achieve high chemotherapy compliance in the CRT arm (approximately 70%), delivered optimal treatment time in both arms (<56 days), and provided toxicity management. The results of the study are encouraging, with significant improvement in DFS and OS in patients treated with CRT compared with RT alone, with 5-year absolute DFS and OS benefit of 9% and 8%, ARTICLE INFORMATION

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Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

Cited by 69 publications

References 15 publications

Comparing Weekly versus Three Weekly Schedules of Cisplatinum Concomitant with Radical Radiotherapy in Locally Advanced Carcinoma Uterine Cervix

Comparing Weekly versus Three Weekly Schedules of Cisplatinum Concomitant with Radical Radiotherapy in Locally Advanced Carcinoma Uterine Cervix

A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer

Concurrent Chemoradiotherapy for Stage IIIB Cervical Cancer—Global Impact Through Power

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