Primary Vaginal Cancer Treated With Concurrent Chemoradiation Using Cis-Platinum

Rajiv Samant, IJROBP 2007;69:746
Purpose

To evaluate the feasibility of concurrent weekly Cis-platinum chemoradiation (CRT) in the curative treatment of primary vaginal cancer.

Methods

A retrospective review was performed of all primary vaginal cancer patients treated with curative intent at the Ottawa Hospital Regional Cancer Centre between 1999 and 2004 using concurrent Cis-platinum CRT.

Results

Twelve patients were treated with concurrent weekly CRT. The median age at diagnosis was 56 years (range, 34–69 years), and the median follow-up was 50 months (range, 11–75 months). Ten patients (83%) were diagnosed with squamous cell carcinoma and 2 patients (17%) with adenocarcinoma. The distribution according to stage was as follows: 6 (50%) Stage II, 4 (33%) Stage III, and 2 (17%) Stage IVA. All patients received pelvic external beam radiotherapy (EBRT) concurrently with weekly intravenous Cis-platinum chemotherapy (40 mg/m2) followed by brachytherapy (BT). The median dose of EBRT was 4500 cGy given in 25 fractions over 5 weeks. Ten patients received interstitial BT, and 2 patients received intracavitary BT, with the median dose being 3000 cGy. T

he 5-year overall survival, progression-free survival, and locoregional progression-free survival rates were 66%, 75%, and 92%, respectively. Late toxicity requiring surgery occurred in 2 patients (17%).

Conclusions

For the treatment of primary vaginal cancer, it is feasible to deliver concurrent weekly Cis-platinum chemotherapy with high-dose radiation, leading to excellent local control and an acceptable toxicity profile.

Discussion

Although radiation is often used in the management of primary vaginal cancer, it can be difficult to treat successfully, especially for locally advanced disease  Local failures have been the major sites of recurrences, and attempts have been directed at improving locoregional control. This is highlighted by the fact that the best published results with radiotherapy have been obtained using a combination of EBRT and BT and, despite these efforts, the rates of locoregional failures at 5 years are still greater than 25%

The impressive results of CRT in the treatment of cervical cancer, often using concurrent Cis-platinum-based chemotherapy, as well as the dramatic responses of chemoradiation when used for locally advanced vulvar cancers has led oncologists to speculate that this approach could be helpful in vaginal cancers as well because of the similar etiology, histology, and patterns of disease progression in these three types of cancers. Because of its rarity, published series of CRT regimens for vaginal cancers are necessarily small in size, like the one presented here. It would likely take a decade or more even for large referral-based centers to be able to accumulate a modest cohort of patients.

Our study is the only published series specifically reviewing outcomes with a weekly concurrent Cis-platinum CRT approach for primary vaginal cancer. Our results compare very favorably with the published radiotherapy literature using combined EBRT and BT. Our findings highlight the high rates of locoregional control that can be achieved with a CRT regimen and suggest that most vaginal cancer patients being treated with an aggressive approach using EBRT combined with concurrent weekly Cis-platinum followed by BT can be cured with an acceptable level of toxicity. Owing to the small number of patients in our study, we are not able to analyze and correlate outcomes according to stage, grade, or histology. However, it is interesting to note that both of the patients with lymph node involvement relapsed, compared with only one relapse among the remaining 10 patients without lymph node involvement.

Given that in most published studies of vaginal cancer vaginal and pelvic recurrences predominate and are the principle causes of treatment failure and death, it is reasonable to expect that improving locoregional control should lead to better survival. Using a weekly Cis-platinum-based CRT approach, we achieved excellent local control, with only one of the three failures occurring within the pelvis. Therefore, we believe that Cis-platinum has the potential to enhance locoregional control by acting as a radiation sensitizer. Patients were generally able to tolerate and complete treatment as prescribed. The addition of chemotherapy did not seem to increase radiation-related long-term side effects: severe (Grade ≥3) late gastrointestinal toxicity requiring surgery in our series was similar to the 10–15% reported elsewhere in the literature with the use of radiation alone Also notable in our series was the significant vaginal fibrosis after treatment; however, it remains uncertain whether this was primarily related to the chemotherapy.

Despite our small patient numbers, potential for selection bias, and retrospective analysis, we believe that our findings are encouraging and deserve further prospective follow-up study. A recently published study by Dalrymple also found chemoradiation to be very effective in the treatment of primary squamous cell carcinoma of the vagina but 93% of their patients (13 of 14) had Stage I or II disease, and they used a 5-fluorouracil-based chemotherapy protocol. They only used intracavitary BT after EBRT, and the total doses of radiation were somewhat lower than ours (median total dose, 6300 cGy) so it remains uncertain whether this approach would be effective in patients with more advanced-stage vaginal cancer. They did not have any patients with fistulae but reported a 31% rate of severe bowel complications, including two deaths from bowel obstruction.

As stated elsewhere  patient selection influences the treatment approach of vaginal cancers, both in terms of radiotherapy approach and utilization of chemotherapy. This is also true for patients in our series, who were all assessed to have a good performance status (generally Eastern Cooperative Oncology Group 0–2), no evidence of metastases outside the pelvis, and were considered suitable for BT. It should be noted that even though half of our patients had Stage III or IVa disease, local control was extremely high (92%). Therefore, our current policy is that concurrent chemoradiation should be considered a treatment option for vaginal cancer patients clinically judged to be candidates for curative treatment. We believe that high doses of radiation (using EBRT followed by BT, a radiotherapy regimen already used in many centers) can be safely combined with concurrent radiosensitizing chemotherapy, such as weekly Cis-platinum. Direct comparisons with results from other centers are not really possible owing to the high degree of patient selection involved in management, and this clearly highlights the need for other centers to publish their results, even if they have relatively small patient numbers.

In addition, chemotherapy combined with newer techniques for delivering high doses of radiation, such as three-dimensional conformal radiotherapy and intensity-modulated radiotherapy, warrant further study, especially in patients not suitable for brachytherapy. At TOHRCC, we have begun a Phase I/II study evaluating concurrent weekly Cis-platinum chemotherapy in conjunction with image-guided intensity-modulated radiotherapy for vaginal cancer patients not considered suitable for interstitial or intracavitary brachytherapy. At present, it remains uncertain whether these sophisticated new techniques can achieve similar rates of locoregional control with acceptable levels of toxicity compared with EBRT plus BT.

Conclusions

Our results should strengthen the argument that concurrent chemoradiation is feasible and effective in the management of primary vaginal cancers and should be considered as an option for patients being treated with curative intent. We hope that our study encourages more radiation oncologists to consider using a combined chemotherapy and radiation regimen, and we eagerly await confirmatory results from other institutions using this type of approach in the treatment of patients with vaginal cancer.