The evidence supporting this protocol with trimodality therapy is provided by two prospective phase II trials showing that pre-operative chemoradiation has superior results compared to historical controls.rr There have also been several retrospective series of patients treated with multimodal protocols for superior sulcus tumours such as Fischer et al., Kappers et al., Robinson et al., Marulli et al., and Li et al.rrrrr
The Southwest Oncology Group 9416 (Intergroup trial 0160) was a prospective multi-institutional phase II trial.r Patient recruitment was between 1995 and 1999. Patients were treated with induction cisplatin and etoposide with concurrent radiation to a dose of 45Gy. Following restaging at two to four weeks, patients with stable or responsive disease underwent thoracotomy. All patients were to receive an additional two cycles of chemotherapy. 95% of patients completed the induction therapy and the R0 resection rate was 87.3%. Overall 5-year survival was 44% with a median survival of 33 months, for patients with complete response, the 5-year survival was 54%. The treatment mortality of induction therapy was 2.7% and the surgical mortality was 2.6%.
The Japan Clinical Oncology Group (JCO9806) phase II trial recruited patients between 1999 and 2002.r Patients were given two courses of mitomycin, vindesine and cisplatin with concurrent radiation (45Gy/25# in a split-course) followed by surgical resection. 57 (76%) patients completed the regimen and a pathologic complete response (R0) was achieved in 51 patients (68%). The 5-year disease free survival and overall survival rates were 45% and 56% respectively. The rate of treatment related deaths during induction treatment was 1.3% and the surgical mortality rate was 3.5%.