Clinical Investigation
Anal Canal Cancer: Management of Inguinal Nodes and Benefit of Prophylactic Inguinal Irradiation (CORS-03 Study)

Presented at the 2010 ASCO GI meeting, Orlando, FL.
https://doi.org/10.1016/j.ijrobp.2011.02.010Get rights and content

Purpose

To evaluate the benefit of prophylactic inguinal irradiation (PII) in anal canal squamous cell carcinoma (ASCC).

Methods and Materials

This retrospective study analyzed the outcome of 208 patients presenting with ASCC treated between 2000 and 2004 in four cancer centers of the south of France.

Results

The population study included 35 T1, 86 T2, 59 T3, 20 T4, and 8 T stage unknown patients. Twenty-seven patients presented with macroscopic inguinal node involvement. Of the 181 patients with uninvolved nodes at presentation, 75 received a PII to a total dose of 45–50 Gy (PII group) and 106 did not receive PII (no PII group). Compared with the no PII group, patients in the PII group were younger (60% vs. 41% of patients age <68 years, p = 0.01) and had larger tumor (T3-4 = 46% vs. 27% p = 0.01). The other characteristics were well balanced between the two groups. Median follow-up was 61 months. Fourteen patients in the no PII group vs. 1 patient in the PII group developed inguinal recurrence. The 5-year cumulative rate of inguinal recurrence (CRIR) was 2% and 16% in PII and no PII group respectively (p = 0.006). In the no PII group, the 5-year CRIR was 12% and 30% for T1-T2 and T3-T4 respectively (p = 0.02). Overall survival, disease-specific survival, and disease-free survival were similar between the two groups. In the PII group, no Grade >2 toxicity of the lower extremity was observed.

Conclusion

PII with a dose of 45 Gy is safe and highly efficient to prevent inguinal recurrence and should be recommended for all T3-4 tumors. For early-stage tumors, PII should also be discussed, because the 5-year inguinal recurrence risk remains substantial when omitting PII (about 10%).

Introduction

Squamous cell cancer of the anal canal (ASCC) is an uncommon malignancy, representing 1.5% of the digestive tract cancers and affecting approximately 5,300 patients per year in the United States and in Europe 1, 2. For a long time, abdominoperineal resection remained the standard of care for anal cancer 3, 4. In the early 1960s, the concept of conservative treatment emerged with Papillon et al. 5, 6. These authors reported the first large experience of long-term local control achieved for anal cancer treated with definitive radiation therapy. Since the first description by Nigro et al. (7) of complete pathologic responses to concurrent 5-fluorouracil, mitomycin C, and radiation therapy in patients with anal cancer, further studies has established primary chemoradiation therapy as the first-line treatment for ASCC 8, 9, 10, 11, 12.

For ASCC, inguinal lymph nodes are a potential site for metastatic dissemination. Inguinal involvement is demonstrated to be a poor prognostic factor 13, 14, 15. For patients with uninvolved inguinal nodes at presentation, the benefit of prophylactic inguinal irradiation (PII) remains questionable because of the potential serious long-term wound and lower extremity complications. As illustration of this controversy, for patients with uninvolved inguinal nodes at presentation, some randomized trials investigating anal cancer treatment systematically omitted the groin irradiation (12), or systematically recommended it 10, 16, 17, whereas in other trials the inguinal irradiation decision was left to the physicians’ choice (18).

This study, leaded by the French collaborative group CORS (Cercle des Oncologues Radiothérapeutes du Sud [Society of Southern France Radio-oncologists]) aims to evaluate the management of inguinal groin in patients with ASCC and to assess the benefit of prophylactic inguinal irradiation.

Section snippets

Patient selection

Between January 1, 2000, and December 31, 2004, patients presenting with ASCC treated in one of the following cancer centers: Antoine-Lacassagne Cancer Center (Nice, France), French Red Cross Center (Toulon, France), Azurean Cancer Center (Mougins, France), and Academic Timone Hospital (Marseille, France) were screened for inclusion in this study. Eligible patients presented with primary invasive squamous cell carcinoma arising in the anal canal, treated through a conservative approach based on

Results

The median follow-up of the population was 61 months (minimum 1, maximum 108).

Discussion

For anal canal cancer, prophylactic inguinal irradiation remains under debate. To our knowledge, this analysis represents the first study, which specifically explores the benefit of inguinal irradiation. The present report suggests a clear benefit of prophylactic inguinal irradiation in patients with N0/1 tumors. This cohort included a large number of patients in a short period of time (5 years) avoiding mistaking factors such as treatment strategy variations during the study period and

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