scholarly journals Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Jing Li ◽  
Hua Liu ◽  
Ya Li ◽  
Jian Li ◽  
Lifei Shen ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Advanced Cervical Cancer ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer ◽  
Disease Free

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 thrice-weekly 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. Based on a 65% of 2-year disease-free survival (DFS) rate in the CCRT group and 80% of that in NACT followed by CCRT group, and on prerequisite conditions including an 8% loss to follow-up, a two-sided 5% of type I error probability, and an 80% of power, a total of 300 cases were required for enrollment. Patients with IIB–IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. In the 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). In the control arm, patients will undergo CCRT treatment. The primary endpoint of the study is 2-year disease-free survival (DFS); the secondary endpoints are 5-year overall survival (OS) and disease-free survival (DFS), the response rate 3 months after treatment completion, grade III/IV adverse effects, and quality of life, and potential biomarkers for predicting treatment response will also be studied. Discussion 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. Registered on 24 August 2019. medresman.org.cn ChiCTR1900025326

Radiation with cisplatin or carboplatin for locally advanced cervix cancer: The experience of a tertiary cancer center.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15541-e15541
Author(s):  
George Au-Yeung ◽  
Linda R. Mileshkin ◽  
David Bernshaw ◽  
Srinivas Kondalsamy-Chennakesavan ◽  
Danny Rischin ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Concurrent Chemotherapy ◽  
Advanced Cervical Cancer ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer ◽  
Distant Failure ◽  
Disease Free

e15541 Background: Definitive treatment with concurrent cisplatin and radiation is the standard of care for locally advanced cervical cancer. The optimal management of patients with a contraindication to cisplatin has not been established. We conducted a retrospective audit of the impact of concurrent chemoradiation in a cohort of patients (pts) with locally advanced cervical cancer. Methods: All pts with locally advanced cervical cancer treated with definitive radiation were entered into a prospective database. Information regarding their demographics, stage, histology, recurrence and survival were recorded. Pharmacy records were reviewed to determine concurrent chemotherapy use. The primary endpoint was overall survival, and secondary endpoints were disease free survival and rates of primary, nodal or distant failure. Univariate and multivariate analyses were performed, incorporating known prognostic factors of age, FIGO stage, uterine body involvement, tumour volume on MRI and nodal involvement. Results: 442 pts were treated from Jan 1996 to Feb 2011. Median age was 59 (range 22-94); 89% had squamous histology and 64% node-negative disease. 269 pts received cisplatin, 59 received carboplatin because of a contraindication to cisplatin and 114 received no concurrent chemotherapy (most prior to 1999). Overall survival adjusted for other prognostic factors was significantly improved with use of concurrent cisplatin compared to radiation alone (HR 0.53, p=0.001), as was disease free survival and the rate of distant failure. Use of concurrent carboplatin was not associated with any significant benefit compared to radiation alone in terms of overall survival or disease free survival on univariate or multivariate analyses. Conclusions: The results of this audit are consistent with the known significant survival benefit with concurrent cisplatin chemoradiation. However, there did not appear to be any significant benefit associated with concurrent carboplatin although there are potential confounding factors in this small cohort. The available evidence in the literature favors the use of non-platinum chemotherapy rather than carboplatin in pts with contraindications to cisplatin.

Adjuvant carboplatin and paclitaxel after concurrent cisplatin and radiotherapy in patients with locally advanced cervical cancer

2019 ◽  
Vol 29 (1) ◽  
pp. 42-47 ◽  
Author(s):  
Guler Yavas ◽  
Cagdas Yavas ◽  
Erdem Sen ◽  
Irem Oner ◽  
Cetin Celik ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Advanced Cervical Cancer ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer ◽  
Grade 3 ◽  
Disease Free

IntroductionStandard treatment for locally advanced cervical cancer (LACC) includes concomitant chemoradiotherapy (CRT) that typically controls localized disease. However, most patients develop distant metastasis, ultimately leading to death.ObjectiveTo determine the role of adjuvant carboplatin and paclitaxel for clinical outcomes in patients with LACC.MethodsBetween 2010 and 2017, 109 patients with LACC were retrospectively evaluated. All patients received cisplatin (40 mg/m2) with concurrent external-beam radiotherapy (up to 50.4 Gy), followed by intra-cavitary brachytherapy. Forty-six of 109 patients received a median of six cycles (range 3–6 cycles) of adjuvant chemotherapy consisting of paclitaxel (175 mg/m2) and carboplatin (CRT + chemotherapy group; area under the curve 5). The remaining 63 patients did not receive adjuvant chemotherapy (CRT group).ResultsDisease-free survival and overall survival after a median follow-up of 24.5 months (range 2.6–94.75 months) were 93.5% and 95.7% and 69.8% and 82.5 % for the CRT + chemotherapy and CRT groups, respectively (p = 0.001, p = 0.012, respectively). No acute grade 3/4 gastrointestinal or genitourinary toxicities were seen during CRT. During adjuvant chemotherapy, the most troublesome side effects were hematologic and neurologic toxicities; however, most were manageable. No chronic grade 3/4 genitourinary toxicities were seen.DiscussionAdjuvant chemotherapy in patients with LACC significantly improved both disease-free survival and overall survival without increasing unmanageable toxicity. Future larger prospective trials are warranted to verify these findings.

Completion Surgery After Intensity-Modulated Arc Therapy in the Treatment of Locally Advanced Cervical Cancer: Feasibility, Surgical Outcome, and Oncologic Results

2013 ◽  
Vol 23 (5) ◽  
pp. 877-883 ◽  
Author(s):  
Philippe Tummers ◽  
Amin Makar ◽  
Katrien Vandecasteele ◽  
Gert De Meerleer ◽  
Hannelore Denys ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Advanced Cervical Cancer ◽  
Bulky Disease ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer ◽  
Intensity Modulated ◽  
Arc Therapy ◽  
Disease Free

IntroductionSince the addition of chemotherapy to radiotherapy, the survival rates of locally advanced cervical cancer (LACC) have improved but are still disappointing. Therefore, the idea of surgery after chemoradiation in case of LACC or bulky disease was adopted. One of the concerns regarding surgery following chemoradiotherapy is surgery-related morbidity.AimThe objectives of this study were to investigate the feasibility of surgery after advanced radiotherapy techniques such as intensity-modulated arc therapy (IMAT) and to describe the morbidity.MethodsThis was a prospective study of primary inoperable LACC patients primary treated with IMAT, in most cases combined with weekly cisplatin. Then the resectability was reevaluated. If resectable patients were treated with Wertheim type 2 surgery ± pelvic lymphadenectomy (on positron emission tomography–computed tomography indication). If tumor is not resectable, patients were treated with brachytherapy.ResultsSince 2006, 41 consecutive patients were included. After neoadjuvant IMAT, 34 were considered resectable and underwent surgery, whereas 7 proceeded with brachytherapy. The operative mortality rate was nil. There were no major perioperative complications. No ureter, bladder, or bowel injuries occurred. No postoperative urinary/digestive fistulae or stenoses were noted. Eleven patients had postoperatively urinary retention problems. At the time of discharge, 5 patients still needed self-catheterization. All problems resolved within 3 months. In 4 cases, we saw significant lymphoceles. In all patients intended to treat, overall survival and disease-free survival at 3 years were 63% and 74%. In the Wertheim group, overall survival and disease-free survival at 3 years were 81% and 91%.ConclusionsCompleting surgery after chemoradiation therapy (with IMAT) for LACC or bulky disease is feasible, and complication rates are comparable with those of primary surgery for cervical cancer.

scholarly journals Surgical versus clinical staging prior to primary chemoradiation in patients with cervical cancer FIGO stages IIB–IVA: oncologic results of a prospective randomized international multicenter (Uterus-11) intergroup study

2020 ◽  
Vol 30 (12) ◽  
pp. 1855-1861 ◽  
Author(s):  
Simone Marnitz ◽  
Audrey Tieko Tsunoda ◽  
Peter Martus ◽  
Marcelo Vieira ◽  
Renato Jose Affonso Junior ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Surgical Staging ◽  
Clinical Staging ◽  
Advanced Cervical Cancer ◽  
Cancer Specific Survival ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer ◽  
Disease Free

ObjectiveRevised staging of patients with locally advanced cervical cancer is based on clinical examination, imaging, and potential surgical findings. A known limitation of imaging techniques is an appreciable rate of understaging. In contrast, surgical staging may provide more accurate information on lymph node involvement. The aim of this prospective study was to evaluate the impact of pre-treatment surgical staging, including removal of bulky lymph nodes, on disease-free survival in patients with locally advanced cervical cancer.MethodsUterus-11 was a prospective international multicenter study including patients with locally advanced cervical cancer who were randomized 1:1 to surgical staging (experimental arm) or clinical staging (control arm) followed by primary platinum-based chemoradiation. Patients with histologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous cancer International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IIB–IVA underwent gynecologic examination and pre-treatment imaging including abdominal computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI). Patients had chest imaging (any of the following: X-ray, CT, or PET-CT). The primary endpoint was disease-free survival and the secondary endpoint was overall survival. An ad hoc analysis was performed after trial completion for cancer-specific survival. Randomization was conducted from February 2009 to August 2013.ResultsA total of 255 patients (surgical arm, n=130; clinical arm, n=125) with locally advanced cervical cancer were randomized. Of these, 240 patients were eligible for analysis. The two groups were comparable with respect to patient characteristics. The surgical approach was transperitoneal laparoscopy in most patients (96.6%). Laparoscopic staging led to upstaging in 39 of 120 (33%) patients. After a median follow-up of 90 months (range 1–123) in both arms, there was no difference in disease-free survival between the groups (p=0.084). For patients with FIGO stage IIB, surgical staging is superior to clinical staging with respect to disease-free survival (HR 0.51, 95% CI 0.30 to 0.86, p=0.011). In the post-hoc analysis, surgical staging was associated with better cancer-specific survival (HR 0.61, 95% CI 0.40 to 0.93, p=0.020).ConclusionOur study did not show a difference in disease-free survival between surgical and clinical staging in patients with locally advanced cervical cancer. There was a significant benefit in disease-free survival for patients with FIGO stage IIB and, in a post-hoc analysis, a cancer-specific survival benefit in favor of laparoscopic staging. The high risk of distant metastases in both arms emphasizes the need for further evaluation.

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

Pelvic Irradiation With Concurrent Chemotherapy Versus Pelvic and Para-Aortic Irradiation for High-Risk Cervical Cancer: An Update of Radiation Therapy Oncology Group Trial (RTOG) 90-01

2004 ◽  
Vol 22 (5) ◽  
pp. 872-880 ◽  
Author(s):  
Patricia J. Eifel ◽  
Kathryn Winter ◽  
Mitchell Morris ◽  
Charles Levenback ◽  
Perry W. Grigsby ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Disease Stage ◽  
Tumor Diameter ◽  
Free Survival ◽  
Stage Ib ◽  
Disease Free

Purpose To report mature results of a randomized trial that compared extended-field radiotherapy (EFRT) versus pelvic radiotherapy with concomitant fluorouracil and cisplatin (CTRT) in women with locoregionally advanced carcinomas of the uterine cervix. Patients and Methods Four hundred three women with cervical cancer were randomly assigned to receive either EFRT or CTRT. Patients were eligible if they had stage IIB to IVA disease, stage IB to IIA disease with a tumor diameter ≥ 5 cm, or positive pelvic lymph nodes. Patients were stratified by stage and by method of lymph node evaluation. Results The median follow-up time for 228 surviving patients was 6.6 years. The overall survival rate for patients treated with CTRT was significantly greater than that for patients treated with EFRT (67% v 41% at 8 years; P < .0001). There was an overall reduction in the risk of disease recurrence of 51% (95% CI, 36% to 66%) for patients who received CTRT. Patients with stage IB to IIB disease who received CTRT had better overall and disease-free survival than those treated with EFRT (P < .0001); 116 patients with stage III to IVA disease had better disease-free survival (P = .05) and a trend toward better overall survival (P = .07) if they were randomly assigned to CTRT. The rate of serious late complications of treatment was similar for the two treatment arms. Conclusion Mature analysis confirms that the addition of fluorouracil and cisplatin to radiotherapy significantly improved the survival rate of women with locally advanced cervical cancer without increasing the rate of late treatment-related side effects.

Neoadjuvant chemotherapy plus radical surgery followed by chemotherapy in locally advanced cervical cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5093-5093
Author(s):  
Roberto Angioli ◽  
Francesco Plotti ◽  
Corrado Terranova ◽  
Michela Angelucci ◽  
Irma Oronzi ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Radical Surgery ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Platinum Based Chemotherapy ◽  
Node Metastases

5093 Background: The aim of this study is to evaluate the efficacy, in terms of overall survival and progression free survival, and safety of adjuvant chemotherapy after neoadjuvant chemotherapy followed by radical surgery both in patients with and without node metastases. Methods: Between June 2000 to May 2007, all patients with diagnosis of locally advanced cervical cancer referred to the Division of Gynecologic Oncology of the University Campus Bio-Medico of Rome were elegible for this protocol.All enrolled patients received 3 cycles of platinum-based chemotherapy every 3 weeks according to the scheme cisplatin 100 mg/mq and paclitaxel 175 mg/mq. After neoadjuvant chemotherapy all patients with stable or progression to treatment were excluded from the protocol, all other were submitted classical radical hysterectomy and bilateral systematic pelvic lymph node dissection, and after to adjuvant treatment with 6 cycles of platinum based chemotherapy with cisplatin 100 mg/mq and paclitaxel 175 mg/mq. Results: 110 patients with local advanced cervical cancer received the treatment with neoadjuvant chemotherapy followed by radical surgery and adjuvant chemotherapy.Our study focused on clinical and operative data , in terms of overall survival and disease free survival at 5 and 3 years. 5-year OS of our series was 78% at five years and 86% at 3-years, with encouraging results also in subgroup with and without node mestastases. Conclusions: The adjuvant chemotherapy regimen after neoadjuvant chemotherapy and radical surgery rappresents a valid treatment option for patients with locally advanced cervical cancer without lymph node involvement, both in terms of overall survival than in terms of disease-free interval, the results have also confirmed the validity of this approach in lymph node metastases, with a complication rate lower than the standard radio-chemotherapy regime.

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