Radiation therapy with concomitant and adjuvant cisplatin and paclitaxel in high-risk cervical cancer: Long-term follow-up
ABSTRACT Chemo-potentiation of radiation improves survival in women with cervical cancer. Our group has previously demonstrated the tolerability of weekly paclitaxel combined with cisplatin during radiation therapy. We sought to determine the efficacy of this regimen in patients with "high risk" cervical cancer, and to determine the short- and long-term toxicity of this approach.
We prospectively enrolled surgically staged patients with positive peritoneal cytology, resectable nodal metastases, or primary tumor > 6 cm. Patients were treated using external beam radiation with concomitant cisplatin (50 mg/m2) during weeks 1, 4, and 7, and weekly paclitaxel (50 mg/m2), followed by four courses of adjuvant cisplatin (50 mg/m2) and paclitaxel (135 mg/m2). Toxicity, overall, and disease-free survival were evaluated.
Twenty-three patients were enrolled, and 21 were evaluable. Patient allotment by FIGO stage was: IB1 - seven, IB2 - five, IIA - two, IIB - four, IIIB - two, IV - three. Twenty patients (95%) completed radiation treatment (median dose to point A was 8278 cGy). Seventeen patients (81%) completed all chemotherapy. At a median follow-up of 58 months the overall survival was 68%. Overall survival for patients with clinical Stage I and II disease was 82% at a median of 64 months. Hematologic toxicity was common but rarely resulted in treatment delays. Late complications requiring intervention (obstruction, fistula, significant lymphocyst) occurred in 11 patients (52%).
The combination of paclitaxel and cisplatin appears efficacious in "high-risk" cervical cancer patients. Hematologic toxicity was common but tolerable. Long-term survival was common in these patients, however late toxicity was significant. This regimen should be investigated in collaborative phase III trials.
- SourceAvailable from: Airton T SteinThe Cochrane Library, 01/2005;
- [Show abstract] [Hide abstract]
ABSTRACT: Patients with early stage cervical cancer (stages IA2, IB1 or IIA) with risk factors such as lymph node metastasis, lympho vascular space invasion, depth invasion of more than 10mm, microscopic parametrial invasion, non-squamous histology and positive surgical margins have a high risk of recurrence when compared to patients with early stage cervical cancer with no risk factors for recurrence. To evaluate the effectiveness and safety of platinum-based adjuvant chemotherapy after radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer (stages IA2, IB1 or IIA). We searched the Cochrane Gynaecological Cancer Group Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library Issue 1, 2009), MEDLINE, EMBASE, LILACS, BIOLOGICAL ABSTRACTS and Cancerlit, the National Research Register and Clinical Trials register, with no language restriction. Abstracts of scientific meetings and the citation lists of included studies and other relevant publications were checked through hand searching and experts in the field were contacted to identify further reports of trials. Randomised controlled trials (RCTs) comparing adjuvant radiotherapy with adjuvant radiotherapy and cisplatin-chemotherapy after radical surgery for early stage cervix cancer were included. Two review authors extracted data independently to assess whether the studies met the specified inclusion criteria. Any discrepancies were solved by a third and a forth review author. Meta-analysis was performed using a random effects model, with death and disease progression as outcomes. Three trials were included. Two trials enrolling 325 participants, of whom 297 (91%) were assessed and compared radiotherapy and chemotherapy with radiotherapy alone found that adjuvant chemotherapy significantly reduced the risk of death (hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.36 to 0.87) and disease progression (HR = 0.47, 95%CI: 0.30 to 0.74), with no heterogeneity between trials (I(2) = 0% for both meta-analyses). One trial assessing 71 participants compared chemotherapy followed by radiotherapy with radiotherapy alone and found no significant difference between the two groups (HR = 1.34; 95%CI: 0.24 to 7.66). The median follow up of patients varied from 29 to 42 months. The addition of platinum-based chemotherapy to radiotherapy may offer clinical benefit in the adjuvant treatment of early stage cervical cancer with risk factors for recurrence. However, the evidence is limited because the selected studies were quantitatively and qualitatively limited, with small number of patients and limited period of follow-up.Cochrane database of systematic reviews (Online) 02/2009; DOI:10.1002/14651858.CD005342.pub2 · 5.94 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma. Between May 2000 and May 2004, 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m² Cisplatin (group I; 16 patients) or 50 mg/m² paclitaxel (group II; 15 patients) concurrently with radiotherapy. Median total dose to point A was 74 Gy (range: 66-92 Gy) for group I and 66 Gy (range: 40-98 Gy) for group II. Median follow-up time was 46 months. Patient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (44%) of group I and 8 patients (53%) of group II developed tumor recurrence. The Median Survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively. This small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix.Radiation Oncology 09/2010; 5:84. DOI:10.1186/1748-717X-5-84 · 2.36 Impact Factor