Progression was assessed every 3 months and was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) in the case of measurable disease11 and according to an assessment of the worsening of symptoms or increasing disease (as determined by the patient’s oncologist) in the case of nonmeasurable disease. After progression, overall survival was assessed every 6 months for the first 2 years from the time of random assignment and then annually for the next 2 years. Follow-up beyond 4 years was not required, although 32 patients without progression at 48 months continued to be followed.