A phase II study of dose-dense neoadjuvant chemotherapy with weekly paclitaxel and carboplatin followed by chemoradiation in locally advanced cervical carcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5104-5104
Author(s):  
Rajkumar Bikramjit Singh ◽  
Lalit Kumar ◽  
Subhash Chandra ◽  
B. K Mohanti ◽  
Sushmita Pathy ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Weekly Paclitaxel ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Grade 3 ◽  
Dose Dense

5104 Background: We prospectively studied dose dense neoadjuvant chemotherapy (NACT) designed for an enhanced cell kill, better local control and eradication of micrometastases prior to standard concurrent chemoradiation (CRT) in locally advanced cervical cancer. Methods: Between June 2010 and December 2011, 21 patients (median age - 51 years, range 35 - 67) of cervical cancer with locally advanced disease received NACT using paclitaxel (60mg/m2) and carboplatin (AUC-2) weekly for 6 doses. Patients (pts) then received concurrent CRT (external and brachytherapy) with weekly cisplatin (40mg/m2 for 6 doses) at a mean interval of 15 days (range 7–20 days). The primary end-point was response rate i.e. complete response (CR) and partial response (PR) 12 weeks post CRT. Results: Baseline stages were: stage 2A - 19%, 3B - 71.4%, 4A - 9.5%. Squamous cell carcinoma and adenocarcinoma constituted 95.2% and 4.7% pts respectively. Following NACT, 66.6% pts responded (CR -9.5% %; PR – 57.1 %), 23.8% had stable disease (SD) and 4.7% had progressive disease (PD). A total of 18 pts completed NACT and CRT of which 17 were in CR and 1 in PR. One patient with stage 4A disease developed vesicovaginal fistula at end of NACT for which she underwent pelvic exenteration and was in pathological CR. After NACT, one patient developed choroid metastases and was taken off study protocol while another patient was lost to follow up. At a mean follow up 5.8 months (range 1 - 14), 90% pts were in CR, 5% in PR and 5% had PD. During NACT, Grade 3/4 neutropenia, thrombocytopenia and anemia were seen in 33.3%, 4.7% & 9.5% of pts, respectively and grade 3/4 non-hematological toxicities in 9.5% pts. Following CRT, Grade 3/4 neutropenia, thrombocytopenia and anemia were seen in 25%, 5% and 10% of pts, respectively while 20% pts had grade 3/4 non-hematological toxicities. G-CSF was used in 30% pts during NACT and 25% pts during CRT, respectively. Conclusions: NACT with weekly paclitaxel and carboplatin followed by radical CRT is feasible and is associated with a high response rate in locally advanced cervical cancer. This approach needs to be studied in a phase III trial.

scholarly journals A phase II study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5586-5586 ◽  
Author(s):  
M. McCormack ◽  
J. A. Ledermann ◽  
M. A. Hall-Craggs ◽  
R. P. Symonds ◽  
V. Warwick ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Haematological Toxicity ◽  
Phase Iii ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Grade 3 ◽  
Dose Dense

5586 Background: Chemoradiation (CRT) is the standard of care for locally advanced cervical cancer but survival is poor among women with large tumours, advanced stage, or positive nodes. Neoadjuvant chemotherapy (NACT) prior to CRT to down-stage tumours and lengthen the exposure to systemic treatment is designed to improve outcome. Methods: Patients (pts) with locally advanced cervical cancer received dose-dense carboplatin (AUC2) and paclitaxel (80 mg/m2) weekly, for 6 cycles, followed by CRT (external and brachytherapy) in week 7 with weekly cisplatin (40 mg/m2). The primary end-point was complete and partial response rate (RR) 12 weeks post CRT. Secondary objectives were RR for NACT at 6 weeks, toxicity and survival. The target RRs were 50% and 85% for NACT and post CRT (12-weeks) respectively. Results: Baseline characteristics were: median age at diagnosis 43 yrs (23–71); 74% squamous-, 20% adeno- and 6% adenosquamous carcinomas; FIGO stage IB2 (11%), II (50%), III (33%), IV (6%). The trial closed in Oct 08 with 46 pts. Of the first 36 pts enrolled 9 failed to complete protocol therapy (7 did not complete 6 NACT cycles, 2 did not complete the pre-specified minimum of 4 cycles of concomitant cisplatin). Using data currently available, the RR associated with NACT is 72% (95% CI 53–86%), and 81% at 12 weeks (95% CI 63–92%). Nonhaematological grade 3/4 toxicity was rare (<5%). There was grade 2 alopecia in 25% pts. Grade 3 and 4 haematological toxicity was seen in 10% and <3% of pts respectively. Updated results, including survival, will be presented for all pts. Conclusions: Dose-dense weekly NACT chemotherapy with carboplatin and paclitaxel followed by radical CRT is associated with a high response rate and is feasible. This approach merits further investigation in a phase III trial. [Table: see text]

Use of carboplatinum as neoadjuvant setting for patients affected by locally advanced cervical cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15553-e15553
Author(s):  
Carlo De Cicco Nardone ◽  
Francesco Plotti ◽  
Michela Angelucci ◽  
Roberto Montera ◽  
Patrizio Damiani ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Complete Response ◽  
World Health ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Grade 3 ◽  
Health Organization

e15553 Background: The aim of this study is to evaluate the efficacy and safety of the combination of carboplatin and paclitaxel as neoadjuvant chemotherapy (NACT) in patients affected by locally advanced cervical cancer. Methods: Between June 2007 to May 2009, all patients with diagnosis of IB2-IIB cervical cancer were considered eligible for this protocol. All enrolled patients received 3 cycles of carboplatin (AUC6) and paclitaxel at 175 mg/mq in neadjuvant setting. The chemotherapy induced toxicity and response to the treatment were evaluated according to World Health Organization criteria. Results: We have enrolled 23 patients with diagnosis of locally advanced cervical cancer. A total of 22 patients completed planned 3 cycles of neoadjuvant chemotherapy. After 3 cycles of chemotherapy 9 out of 23 patients (42%) showed a complete response, 7 patients (35%) partial response, 5 patients (16%) stable disease and 2 patients (11%) showed disease progression. The most common toxicity was haematologic (43%), extra haematologic toxicities were nausea/vomiting, neuropathy and alopecia, that occurred in 45%, 13% and 25% respectively. No renal and grade 3 and 4 haematologic toxicities were registered. Conclusions: Our results suggest that the use of carboplatin, in neadjuvant setting, is a well tolerated drug, produces manageable toxicity with a response rate similar to standard cisplatin. Then, it rappresents a valid alternative in patients affected by locally advanced cervical cancer.

A Modified Shortened Administration Schedule for Neoadjuvant Chemotherapy With Irinotecan and Cisplatin in Locally Advanced Cervical Cancer

2011 ◽  
Vol 21 (4) ◽  
pp. 685-689 ◽  
Author(s):  
Yufeng Ren ◽  
Yanfang Li ◽  
Jihong Liu
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Complete Response ◽  
Advanced Cervical Cancer ◽  
Administration Schedule ◽  
Locally Advanced Cervical Cancer ◽  
Grade 3 ◽  
Clinical Records

Introduction:The commonly used administration schedule of irinotecan in combination therapy with cisplatin in cervical cancer was once weekly for 3 weeks. To some extent, this administration schedule may be inconvenient for patients who were far from hospital. The aim of the current study is to investigate the efficacy and toxicities of a modified shortened administration schedule for neoadjuvant chemotherapy with irinotecan and cisplatin in locally advanced cervical cancer.Methods:We retrospectively reviewed the clinical records of patients with cervical cancer who received neoadjuvant chemotherapy with irinotecan and cisplatin delivered by the modified administration schedule at Sun Yat-sen University Cancer Center from November 2005 to May 2010. Irinotecan was administrated by intravenous infusion for 1 hour at a dose of 80 mg/m2on days 1 and 8. Cisplatin was administrated intravenously at a total dose of 60 to 70 mg/m2, which was infused on day 1 or was divided into 2 or 3 doses and given on days 1 to 2 or 3. The treatment was repeated every 3 weeks.Results:The total response rate was 78.8% (42/52), including a complete response and partial response rate of 11.5% (6/52) and 67.3% (35/52), respectively. Pathologically confirmed complete response was noted in 7.7% (4/52) of patients. Stable disease was observed in 17.3% (9/52) of patients and progression disease in 3.8% (2/52) of patients. Diarrhea and hematological toxicity were the major dose-limiting toxicities. Diarrhea occurred in 23.1% of patients with grades 1, 2, and 3 in 11.5%, 7.7%, and 3.8% of patients, respectively. No grade 4 diarrhea was noted. Grade 3/4 neutropenia developed in 7.7% (4/52) of patients. Grade 3/4 anemia occurred in 19.2% (10/52) of patients.Conclusions:The modified shortened administration schedule of combined therapy with irinotecan and cisplatin may be active against cervical cancer as neoadjuvant chemotherapy. The adverse effects could be controllable.

scholarly journals The Safety and Efficacy of Intra-Arterial versus Intravenous Neoadjuvant Chemotherapy in Patients with Locally Advanced Cervical Cancer: A Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Cheng Liu ◽  
Ran Cui ◽  
Miaomiao Li ◽  
Ying Feng ◽  
Huimin Bai ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Clinical Response ◽  
Response Rate ◽  
Meta Analysis ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Safety And Efficacy ◽  
Locally Advanced Cervical Cancer ◽  
Grade 3

Objective. The aim of this study was to evaluate the safety and efficacy of intra-arterial versus intravenous neoadjuvant chemotherapy for the management of patients with locally advanced cervical cancer. Methods. The PubMed, EMBASE, PMC, Web of Science, and Cochrane databases were searched to identify correlational studies published in English. Prospective controlled studies that evaluated the treatment effect of intra-arterial neoadjuvant chemotherapy or intravenous neoadjuvant chemotherapy in patients with locally advanced cervical cancer were pooled for a meta-analysis. Results. A total of three eligible studies with 112 patients with locally advanced cervical cancer were eventually included in this analysis. The baseline regimen of neoadjuvant chemotherapy was platinum-based chemotherapy. The total clinical response rate was 71.4%, and the overall pathological complete response (CR) rate was 11.5%. The grade 3/4 toxicity rate was 27.2%. In the intra-arterial group, the response rate was 83.1% (CR, 22.0%; partial response (PR), 61.0%), which was significantly higher than 58.5% (CR, 11.3%; PR, 47.2%) in the intravenous group (P=0.01). The pathological CR rate was 15.5% in the intra-arterial group, which was higher than 6.5% in the intravenous group. The grade 3/4 toxicity rate was 17.2% in the intra-arterial group, which was higher than the rate of 13.8% in the intravenous group. Conclusion. Platinum-based neoadjuvant chemotherapy was well tolerated in patients with locally advanced cervical cancer and showed moderate response activity. Compared to intravenous neoadjuvant chemotherapy, intra-arterial neoadjuvant chemotherapy had an evident advantage in terms of the clinical response while maintaining a similar toxicity rate. The clinical efficacy of intra-arterial neoadjuvant chemotherapy deserves further evaluation.

Dose-Dense Neoadjuvant Chemotherapy plus Radical Surgery in Locally Advanced Cervical Cancer: A Phase II Study

Oncology ◽  
2015 ◽  
Vol 89 (2) ◽  
pp. 103-110 ◽  
Author(s):  
Pierluigi Benedetti Panici ◽  
Innocenza Palaia ◽  
Claudia Marchetti ◽  
Ilary Ruscito ◽  
Margherita Fischetti ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Radical Surgery ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Dose Dense

Dose dense neoadjuvant chemotherapy (NACT) with carboplatin-paclitaxel in locally advanced cervical cancer.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 5534-5534
Author(s):  
Domenica Lorusso ◽  
Ilaria Sabatucci ◽  
Giuseppa Maltese ◽  
Stefano Lepori ◽  
Elisa Tripodi ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Dose Dense

A phase II study: dose-dense carboplatin and paclitaxel as neoadjuvant chemotherapy in locally advanced cervical cancer

2018 ◽  
Vol 30 (4) ◽  
pp. 247-252 ◽  
Author(s):  
Vera Loizzi ◽  
Vittoria Del Vecchio ◽  
Francesco M. Crupano ◽  
Valentina Minicucci ◽  
Valeria V. Fumarulo ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Dose Dense ◽  
Study Dose

scholarly journals Comparison of Outcomes and Side Effects for Neoadjuvant Chemotherapy with Weekly Cisplatin and Paclitaxel Followed by Chemoradiation versus Chemoradiation Alone in Stage IIB-IVA Cervical Cancer: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Jing Li ◽  
Rong Cai ◽  
Hua Liu ◽  
Lifei Shen ◽  
Wenqing Long ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Phase Iii ◽  
Advanced Cervical Cancer ◽  
Cancer Trial ◽  
Locally Advanced Cervical Cancer

Abstract Background Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (NACT) followed by CCRT may be superior to a triweekly regimen of NACT and CCRT. Among patients who had not received prior cisplatin, a cisplatin and paclitaxel (TP) regimen resulted in longer overall survival than other regimens. This study aims to investigate the feasibility, safety and efficacy of NACT with weekly TP followed by CCRT. Methods This is a prospective, randomized, open-labeled, multicentered Phase III study with a sample size of 300. Patients with IIB-IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. Study arm: patients will receive dose-dense cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly for 4 cycles followed by CCRT (45 Gy in 5 weeks concurrent with cisplatin 40 mg/m2 weekly) plus image-guided adaptive brachytherapy (IGBRT). Control arm: patients will undergo CCRT treatment. The primary endpoints of the study are overall survival rate and disease-free response rate; the secondary endpoint is the response rate 3 months after treatment completion; the tertiary endpoints are grade 3–4 adverse effects and quality of life; and potential biomarkers for predicting treatment response will also be studied. Conclusions The data gathered from the study will be used to determine whether NACT with weekly TP followed by CCRT may become an optimized treatment for locally advanced cervical cancer. Trial Registration Chinese clinical trial registry, ChiCTR1900025327; http://www.chictr.org.cn. Registered 24 August 2019 - Retrospectively registered, medresman.org.cn/ChiCTR1900025326

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