Phase II Study of Consolidation Chemotherapy after Adjuvant or Primary Concurrent Chemoradiation Using Paclitaxel and Carboplatin to Treat High-Risk Early-Stage or Locally Advanced Cervical Cancer

Kim, Hee Seung; Kim, Mi Kyung; Kim, Hak Jae; Han, Seung Su; Kim, Jae Weon

doi:10.4143/crt.2012.44.2.97

Cited by 23 publications

(16 citation statements)

References 23 publications

(27 reference statements)

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“…So far, including ours, two studies have evaluated the efficacy of TC-based CCRT followed by consolidation chemotherapy. Kim et al [20] employed a 3 weekly schedule in stage IIB–IVA patients and reported 3-year PFS and OS rates of 51.9% and 60.0%, respectively. In contrast, although we included cases of more advanced disease (stage IIIB/IVA), we achieved better oncological outcomes; i.e., 3-year PFS and OS rates of 67.9% and 90.8%, respectively.…”

Section: Discussionmentioning

confidence: 99%

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Chemoradiotherapy followed by consolidation chemotherapy involving paclitaxel and carboplatin and in FIGO stage IIIB/IVA cervical cancer patients

et al. 2017

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ObjectiveTo evaluate the efficacy and toxicity of paclitaxel plus carboplatin (TC)-based concurrent chemoradiotherapy (CCRT) followed by consolidation chemotherapy in the International Federation of Gynecology and Obstetrics (FIGO) stage IIIB/IVA cervical cancer patients.MethodsWe reviewed the medical records of FIGO stage IIIB/IVA cervical cancer patients (n=30) who had been intended to be treated with TC-based CCRT followed by consolidation chemotherapy (TC-CCRT-group) from April 2012–May 2016. Patients who had been treated with CCRT involving a single platinum agent (CCRT-group; n=52) or definitive radiotherapy alone (RT-group; n=74) from January 1997–September 2012 were also identified and used as historical controls. Survival was calculated using the Kaplan-Meier method and compared using the log-rank test.ResultsOf the 30 patients included in the TC-CCRT-group, 22 patients (73.3%) completed the planned TC-based CCRT. The most frequently observed acute grade 3/4 hematological toxicities were leukopenia and neutropenia, and diarrhea was the most common acute grade 3/4 non-hematological toxicity. After a median follow-up of 35 months, 9 patients (30.0%) had developed recurrent disease. The patients’ estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 67.9% and 90.8%, respectively. In comparisons with historical control groups, the survival outcomes of TC-CCRT-group was significantly superior to CCRT-group in terms of OS (p=0.011) and significantly superior to RT-group in terms of both PFS (p=0.009) and OS (p<0.001).ConclusionTC-based CCRT followed by consolidation chemotherapy is safe and effective. A randomized controlled study needs to be conducted to further evaluate the efficacy of this multimodal approach in this patient population.

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Section: Discussionmentioning

confidence: 99%

“…However, in the setting of definitive radiotherapy, although several clinical trials have been conducted [151617181920], there is limited information available regarding the efficacy and toxicity of TC-based chemoradiotherapy followed by consolidation chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

Chemoradiotherapy followed by consolidation chemotherapy involving paclitaxel and carboplatin and in FIGO stage IIIB/IVA cervical cancer patients

et al. 2017

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“…28 However, prolonged hemotoxicity may hinder the delivery of consolidation chemotherapy, especially in Chinese people. Previous studies have shown that BM requires an extended period to recover from radioactive damage after exposure to a higher dose of radiation (30Y50 Gy).…”

Section: Discussionmentioning

confidence: 99%

Correlations Between Radiation Dose in Bone Marrow and Hematological Toxicity in Patients With Cervical Cancer: A Comparison of 3DCRT, IMRT, and RapidARC

Chang¹,

Yang²,

Li³

et al. 2016

Int J Gynecol Cancer

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“…It was not determined from their study whether the effect of the chemotherapy was as a radiation sensitiser or as a systemic chemotherapy with elimination of possible micrometastasis, or both. In contrast, Kim HS et al found that consolidation chemotherapy after CCRT using paclitaxel and carboplatin failed to improve PFS and OS as compared to CCRT-only in patients with high-risk early-stage cervical cancer who underwent surgical treatment (3-year PFS, 62.7% vs. 88.2%, respectively; 3-year OS, 90.9% vs. 97.3%, respectively) [ 26 ]. However, is there any role for consolidation chemotherapy following CCRT in intermediate-risk cervical cancer patients?…”

Section: Discussionmentioning

confidence: 99%

Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy

et al. 2015

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BackgroundIn cervical cancer patients with intermediate-risk factors, the optimal adjuvant therapy is still controversial. We undertook a randomized trial (ClinicalTrials.gov Identifier: NCT01418859) to compare the efficacy and toxicity of concurrent chemoradiotherapy with topotecan and cisplatin with radiotherapy alone in intermediate-risk cervical cancer patients.MethodsEligible patients were randomly assigned to one of three treatment arms including arm A (radiotherapy only,RT), arm B(concurrent chemoradiotherapy only, CCRT), and arm C (concurrent chemoradiotherapy with following consolidation chemotherapy, CCRT + CT). All eligible patients completed external RT (IMRT or 3D-CRT), receiving 45-50Gy /25f uniformly to the pelvis. Concurrent chemotherapy regimen was topotecan 0.75 mg/m2 for days 1, 2 and 3, followed by cisplatin 25 mg/m2 for days 1, 2 and 3. Three cycles of consolidation chemotherapy regimen was topotecan 1.5 mg/m2 for days 1 and 2, and 0.75 mg/m2 for day 3; followed by cisplatin 25 mg/m2 for days 1, 2 and 3, repeated every 21 days. Adverse events of each group were investigated and compared.ResultsThirty-nine patients enrolled onto the remaining regimens: 14 to RT, 15 to CCRT and 10 to CCRT + CT. Six patients (15.4%) did not complete the protocol treatment. Hematologic toxicity was more frequent and more severe in the CCRT and CCRT + CT arms compared with the RT arm. The incidence of grade 3-4 neutropenia was significantly different statistically between the RT, CCRT and CCRT + RT groups (15.4%, 46.7% and 100%, respectively; P = 0.002). Specially, three patients in CCRT + CT arm of all six patients who did not complete the protocol treatment discontinued planned therapy because of persistent grade 4 neutropenia. However, there were no significant differences in grade 3-4 non-hematologic toxicities between the three groups(all P > 0.05). Recurrence-free survival and overall survival of each group were not analyzed on account of a median follow-up of only 16 months.ConclusionsConcurrent chemoradiotherapy with topotecan and cisplatin showed severe hematologic toxicity in intermediate-risk cervical cancer patients after radical hysterectomy. Thus, the study was closed ahead of schedule.Trial registrationClinicalTrials.gov Identifier: NCT01418859.

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Phase II Study of Consolidation Chemotherapy after Adjuvant or Primary Concurrent Chemoradiation Using Paclitaxel and Carboplatin to Treat High-Risk Early-Stage or Locally Advanced Cervical Cancer

Cited by 23 publications

References 23 publications

Chemoradiotherapy followed by consolidation chemotherapy involving paclitaxel and carboplatin and in FIGO stage IIIB/IVA cervical cancer patients

Chemoradiotherapy followed by consolidation chemotherapy involving paclitaxel and carboplatin and in FIGO stage IIIB/IVA cervical cancer patients

Correlations Between Radiation Dose in Bone Marrow and Hematological Toxicity in Patients With Cervical Cancer: A Comparison of 3DCRT, IMRT, and RapidARC

Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy

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