Abstract
Patients (P) selected for phase II trials differ subst. from those who need pall, treatment for sympt. disease. A low PS due to high tumor load is inversely related to ORR. Expectations from the publ. efficacy of any part, treatment are hardly ever met in daily clin. routine, side effects are underestimated and the psych, benefit for the desperate P hardly out-ways the discomfort afflicted by the necessary med. surveillance. In P with dissem. melanoma improvement of ‘time without symptoms and toxicity’ by system, chemother. still is the exception. This was demonstrated by a multicenter trial of the EORTC, undertaken to confirm the except, high ORR of some 45% reported earlier with FOTEMUSTINE . The ORR in 98 highly selected eligible P was 12% (17% DS), thus sign. lower than in earlier monoinstit. trials and reached only 5% (12% DS) in 42 non-eligible P The responsibility of the treating oncologist for his P's quality adjusted life months is stressed.
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