Concurrent Chemotherapy and Pelvic Radiation Therapy Compared With Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix

Background: Five randomized studies have demonstrated a beneficial effect of adding cisplatin-based chemotherapy to radiation therapy in the treatment of cervical carcinoma. In the present phase II study, we evaluated the response and toxicity of ciplatin-Taxol chemotherapy combined with concomitant radiotherapy in patients with locally advanced cervical carcinoma (LACC) and locally recurrent cervical carcinoma (LRCC). Patients and Methods: In 2000, this phase II study was initiated with a chemotherapy regimen of cisplatin (75 mg/m²) and Taxol (175 mg/m²) every 21 days, for four cycles, concomitant with external radiotherapy and high-dose-rate brachytherapy. Pelvic radiotherapy was started 2 weeks after the first chemotherapy cycle, while the first brachytherapy insertion was carried out during the fourth chemotherapy cycle. SCC marker was determined before treatment and after every chemotherapy cycle. Results: All of the 27 patients treated achieved a complete clinical response. Two patients with LACC experienced distant recurrence 22 and 24 months after complete response, respectively, and 1 patient with LRCC had local progression 6 months after the end of radiotherapy. Although generally tolerable, neutropenia grade 3–4 in 4 patients and anemia grade 3 in 2 patients were observed, and 1 patient experienced grade 2 neurotoxicity; toxicity due to radiotherapy was moderate. Conclusions: Concomitant cisplatin-Taxol chemoradiotherapy seems to be well tolerated, and results, even in this small series, are encouraging.

Section: Discussioncontrasting

confidence: 40%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Phase II Trial with Cisplatin-Paclitaxel Cytotoxic Treatment and Concurrent External and Endocavitary Radiation Therapy in Locally Advanced or Recurrent Cervical Cancer

Miglietta¹,

Franzone²,

Centurioni³

et al. 2006

“…Contrary to the previous trials in patients with cervical cancer, which demonstrated a survival benefit for chemoradiotherapy versus radiotherapy alone [8, 9, 10, 11, 12], Pearcey et al [7]observed similar 3- and 5-year survival rates with concurrent cisplatin and radiotherapy versus radiotherapy alone in patients with advanced cervical carcinoma. While there are many possible explanations for the lack of benefit observed with chemoradiotherapy in this trial, one reason may have been a differential drop in hemoglobin levels during therapy (fig.…”

Section: Studies In Patients With Cervical Cancercontrasting

confidence: 47%

Raising Hemoglobin: An Opportunity for Increasing Survival?

Thomas

2002

Although the association between low hemoglobin levels and poorer outcomes in radiation oncology has long been recognized, anemia is often overlooked and untreated. However, a growing body of clinical evidence now indicates that low hemoglobin levels during radiation treatment are associated with decreased response and survival following radiotherapy. For example, a large Canadian retrospective study in patients receiving radical radiotherapy for cervical cancer showed that the 5-year survival rate was 19% higher in those whose hemoglobin during radiation treatment was =12 g/dl compared to those with levels <12 g/dl. The data suggest that clinical trials need to be performed to determine whether increasing hemoglobin levels leads to improved local control and survival. The mechanism by which low hemoglobin levels could cause poorer outcomes is not well understood and needs further elucidation. It is postulated that lower hemoglobin levels resulting in decreased oxygen carrying capacity may lead to increased tumor hypoxia, radiation resistance and increased tumor angiogenesis. The interrelationship of low hemoglobin levels, hypoxia, tumor angiogenesis and survival is explored in this article.

“…In the last few years, several efforts have been made to improve the poor prognosis of patients with locally advanced cervical cancer (LACC), and 5 out of 6 recent clinical trials demonstrated an advantage in terms of disease-free and overall survival in patients treated with concomitant radiation and cisplatin-based chemotherapy [1, 2, 3, 4, 5, 6], which currently represent the gold standard in the treatment of this neoplasia. In addition, among the multimodal treatment strategies attempted, neoadjuvant chemotherapy or chemoradiation followed by radical surgery have also yielded promising results [7, 8, 9, 10].…”

Section: Introductionmentioning

confidence: 99%

Concomitant Radiochemotherapy plus Surgery in Locally Advanced Cervical Cancer: Update of Clinical Outcome and Cyclooxygenase-2 as Predictor of Treatment Susceptibility

Distefano

Ferrandina²,

Smaniotto³

et al. 2004

Objective: We have updated our findings on the efficacy of concomitant radiochemotherapy plus radical surgery in a larger series of patients (n = 54) with locally advanced cervical cancer (LACC). We also investigated the role of cyclooxygenase-2 (COX-2) in this clinical setting. Methods: Radiotherapy was administered to the whole pelvic region (1.8 Gy/day, totaling 39.6 Gy) in combination with cisplatin (20 mg/m²) and 5-fluorouracil (1,000 mg/m²) (both on days 1–4 and 27–30). Radical surgery was performed 5–6 weeks after the end of treatment. Results: A clinical complete or partial response was observed in all 53 evaluable patients (75.5 and 24.5%, respectively). At pathological examination, 23 of 51 patients (45.1%) undergoing radical surgery showed complete response to treatment, 18 patients (35.3%) only had microscopic residual disease, 6 patients (11.7%) had a partial response and 4 (7.8%) had no change in their disease. When logistic regression was applied, the FIGO stage (χ² = 5.28, p = 0.021) and tumor to stroma COX-2 ratio (χ² = 4.72, p = 0.029) retained an independent role in the prediction of the pathologic response to treatment. The 3-year disease-free survival (DFS) was 75.2%, with local relapse-free survival of 86.2% and metastasis-free interval of 89.9% at 3 years. Cases with a high COX-2 ratio showed a shorter DFS than cases with a low COX-2 ratio (p = 0.016). A direct association was shown between COX-2 ratio values and risk of recurrence, as assessed by Cox analysis using COX-2 ratio values as a continuous covariate (χ² = 3.94, p = 0.047). Conclusion: This study confirms the possibility of achieving a very high rate of pathological responses in LACC patients administered chemoradiation plus surgery (3-year DFS 75.2%). Moreover, COX-2 status may play a role in the prognostic characterization and prediction of tumor response.