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

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.

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

International Journal of Gynecological Cancer ◽

10.1097/igc.0b013e3182129b61 ◽

2011 ◽

Vol 21 (4) ◽

pp. 685-689 ◽

Cited By ~ 5

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.5104 ◽

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.

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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/5023405 ◽

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.5586 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 5586-5586 ◽

Cited By ~ 1

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]

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Efficacy of dose-intensive platinum-containing neoadjuvant chemotherapy in the combination treatment for locally advanced cervical cancer

Tumors of female reproductive system ◽

10.17650/1994-4098-2018-14-4-56-64 ◽

2019 ◽

Vol 14 (4) ◽

pp. 56-64

Author(s):

O. A. Smirnova ◽

N. E. Bondarev ◽

E. A. Ulrikh ◽

N. A. Mikaya ◽

A. S. Petrova ◽

...

Keyword(s):

Cervical Cancer ◽

Neoadjuvant Chemotherapy ◽

Pathological Complete Response ◽

Objective Response ◽

Locally Advanced ◽

Complete Response ◽

Small Sample ◽

Pathological Response ◽

Advanced Cervical Cancer ◽

Locally Advanced Cervical Cancer

Objective:to assess the efficacy of dose-intensive platinum-containing neoadjuvant chemotherapy in patients with FIGO stage IB2–IIB locally advanced cervical cancer.Materials and methods.We evaluated the efficacy and toxicity of 3 cycles of intravenous dose-intensive neoadjuvant chemotherapy with either AP regimen (cisplatin 75 mg/m2 and doxorubicin 35 mg/m2) or TP regimen (cisplatin 60 mg/m2 and paclitaxel 60 mg/m2).Results.The study included 105 patients (75 in the AP group and 30 in the TP group) aged between 27 and 63 years (mean age 44 years) with primary verified cervical cancer (T1–2B0–2Nx–0M0). Surgery was performed in 66 patients (88 %) from the AP group and 24 patients (80 %) from the TP group. Six patients (8 %) receiving AP regimen and 1 patient (3.3 %) receiving TP regimen developed disease progression. Four women (2.8 %) from the AP group developed relapses, whereas none of the patients from the TP group had relapses. Dose-intensive chemotherapy did not cause any significant complications at both chemotherapeutic and surgical stages. Our findings suggest that dose-intensive neoadjuvant chemotherapy is an effective method with an objective response rate of 84 % (63 cases) and 56.7 % (17 cases) in groups AP and TP respectively. Fifty-nine patients (78.7 %) receiving AP regimen had pathological response; of them, 7 participants (9.4 %) demonstrated pathological complete response (ypCR). In the TP group, 19 patients (63.3 %) had pathological response and 4 patients (13.4 %) had pathological complete response. Median follow-up time was 16.7 months (range: 3–29 months) in the AP group and 9.1 months (range: 2.8–12.7 months) in the TP group.Conclusion.Dose-intensive neoadjuvant chemotherapy can be considered as an alternative to standard treatment of locally advanced cervical cancer; however, further studies are needed due to the small sample size in this study.

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Phase II study of perioperative combination chemotherapy with triweekly carboplatin and weekly dose dense paclitaxel and radical hysterectomy for locally advanced cervical cancer (SGSG-016 study).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e17022 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e17022-e17022

Author(s):

Shoji Nagao ◽

Ai Kogiku ◽

Michiko Nonaka ◽

Yuko Shiroyama ◽

Tetsuro Oishi ◽

...

Keyword(s):

Cervical Cancer ◽

Locally Advanced ◽

Large Cell ◽

Complete Response ◽

Figo Stage ◽

Weekly Dose ◽

Advanced Cervical Cancer ◽

Locally Advanced Cervical Cancer ◽

Before And After ◽

Grade 3

e17022 Background: The primary objective of this study was to assess efficacy and safety of triweekly carboplatin plus weekly dose dense paclitaxel (ddTC therapy) before and after radical hysterectomy without radiotherapy (RH) for women with locally advanced cervical cancer. Methods: Patients with FIGO stage IB2, IIA2, or IIB cervical cancer received 3 cycles of carboplatin at an area under the curve of 6 on day 1 and paclitaxel at 80mg/m2on day 1, 8, and 15 every 21 days followed by RH. Patients with one or more high-risk factors for recurrence including lymph vascular invasion, parametrial invasion, lymph node matastasis, or positive margin received additional 3 cycles of ddTC therapy after RH. Results: Between September 2014 and July 2016, 50 women including 13 with FIGO stage Ib2, 5 with stage IIa2, and 32 with stage IIb were enrolled in this study. There were 37 squamous cell carcinoma, 10 adenocarcinoma, 2 adenosquamous carcinoma, and 1 large cell neuroendocrine carcinoma. Median age was 46 years (range 30-78). Forty-three women (86%) completed planed 3 cycled of chemotherapy before surgery. The overall response rate was 92% (18 complete response, 28 partial response, 3 stable disease, 1 progressive disease). Forty-nine patients (98%) completed planed radical hystsrectomy, but a patient with invasion to bladder musculature received concurrent radiation therapy instead of surgery. Eleven patients (22%; 10 with SCC, 1 with large cell neuroendocrine carcinoma) achieved pathological complete response. Eleven other patients with one or more high-risk factors received 3 cycles of ddTC therapy after surgery. Grade 3/4 hematological toxicities included neutrocytopenia (58%), thrombocytopenia (2%) and anemia (24%). One patients experienced neutropenic fever. Grade 3/4 non-hematological toxicities were observed in 4 patients (1, grade 3 nausea; 1, grade3 carboplatin allergy; 1, grade 3 paclitaxel allergy; 1 grade 3 elevetaed liver enzyme). Conclusions: Administration of ddTC therapy before and after RH has good efficacy and acceptable toxicity in women with locally advanced cervical cancer. Clinical trial information: UMIN000024136.

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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

10.21203/rs.3.rs-68428/v1 ◽

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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