Washington, DC (UroToday.com) Penile cancer is associated with advanced regional metastasis and poor survival. Prior data suggested a benefit with neoadjuvant chemotherapy in advanced penile cancer. Furthermore, prior data suggest a benefit of neoadjuvant chemoradiation in patients with other squamous cancers. However, there is a limited evidence in penile cancer.
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International Penile Advanced Cancer Trial (INPACT) trial is a prospective clinical trial designed to address the role of neoadjuvant therapy and superiority of neoadjuvant chemotherapy or chemoradaition, and the role of pelvic lymph node dissection in those with prior inguinal lymph node dissection (ILND).
Preoperative risk stratification is done by CT Scan criteria. Low risk group is those with one mobile node with no high-risk features on CT, intermediate risk is those with 2 ipsilateral mobile node with no high risk features on CT, and high risk group is those with bilateral nodes, pelvic nodes, fixed nodes, >3 nodes, or presence of necrosis/extranodal extension on CT scan.
The study is a three-arm study for step 1 (ILND only, Neoadjuvant chemotherapy + ILND, Neoadjuvant chemoradiation + ILND). Neoadjuvant chemotherapy is 4 cycles of paclitaxel, fosfamide, and cisplatin. Neoadjuvant chemoradiation is 45 Gy/25 fractions with weekly cisplatin. Subsequently based on pathological risk assessement the patients are then randomized to chemoradiotherapy + pelvic lymph node dissection or observation + chemoradiotherapy.
Low-risk group is randomized only to ILND. Intermediate-risk group and high-risk group are randomized based on GFR due to chemotherapy limitation. GFR > 50 is classified as those eligible for chemotherapy . Intermediate-risk group with GFR >50 is randomized to all treatment arms. However, intermediate-risk group with GFR < 50 is randomized to either ILND or neoadjuvant chemoradiation. High-risk group is not offered ILND only but are required either neoadjuvant chemoradiation or chemotherapy depending on their GFR.
The study is now open for accrual. The target goal is 400 patients with 200 patients in USA. The primary end-point is overall-survival. The secondary end-points include disease specific survival, pN0 status, toxicity, surgical complications, QOL, and feasibility of delivering treatments on schedule. Tissue from the surgical specimens are planned to be banked for further genomic testing for future research.
INPACT is a unique international, prospective study that is needed for treatment stratification in penile cancer patients.
Curtis A Pittway,MD
MD Anderson Cancer Center
Mohammed Haseebuddin, MD from the Society of Urologic Oncology Meeting - December 2 - 4, 2015 – Washington, DC.