Compliance of physicians and patients with a consensus protocol for treatment of advanced breast cancer.

In a multicenter study we used a consensus protocol including more than five subsequent therapeutic steps for treatment of patients with advanced breast cancer. A total of 335 evaluable patients from 27 participating hospitals were allocated to a low- or high-risk group, receiving different therapies during the initial phase of treatment. About half of these patients were treated without protocol violations (compliers). The protocol non-compliers were divided into three groups: those receiving more intensive therapy than recommended, those with similarly intensive, and those with less intensive therapy. The reasons for protocol violations were analysed. The intensity of the therapy given actually was correlated with the survival of subgroups. Median survival times were significantly longer in 208 low-risk than in 127 high-risk patients (P less than 0.0001), marginally longer in 165 compliers than in 170 non-compliers (P less than 0.04), significantly longer in low-risk compliers than in low-risk non-compliers (P = 0.002), and significantly shorter in high-risk compliers than in high-risk non-compliers (P = 0.007). Survival of all subgroups of low-risk non-compliers was the same regardless of the actual therapies given. The survival of high-risk patients who received less intensive therapy was significantly longer than that of high-risk compliers (P = 0.015). After six cycles of successful chemotherapy there was no difference, either in time to progression or in survival, between patients who had received either maintenance therapy or no therapy. We postulate that the groups of low-risk and high-risk patients comprised patients with different prognoses. Among low-risk patients, survival of the subgroup with poor prognosis (low-risk non-compliers) was not influenced by therapy. Among high-risk patients, a subgroup with poor prognosis may have been overtreated by using standard chemotherapies as recommended in our consensus protocol.

[Concept of treatment of metastatic breast cancer outside university clinics: description of the method and evaluation of efficacy]. / Konzept zur Behandlung metastasierender Mammakarzinome ausserhalb von Universitätskliniken: Beschreibung der Methode und Prüfung der Effizienz.

It has been recognized during the past decade that it may be advantageous to develop complex strategies for treatment of metastatic breast cancer (MBC). In these strategies the type and efficacy of preceding therapies and the compliance of the patients have to be considered. Since about 80% of all patients with MBC are treated outside university hospitals it should be tested if a complex strategy for treatment of MBC can be realized in these institutions. The method was based on three principles: There was an exchange of data between participating institutions and study center after each visit of a patient. Second, there was one data sheet for admission of a patient to the study and fifteen sheets for follow-up documentation each with a different bottom line; in the bottom line of these sheets two therapies according to the strategy were proposed, one in case of 'no progression' and another in case of 'progression' of the disease. Third, a copy of completed sheets had to be returned to the study center; the study center provided the next sheet with the appropriate treatment recommendation. 335 evaluable patients were prospectively recruited from 27 participating institutions between January 1983 and December 1985. Based on the estimated incidence of MBC in the region, it was calculated that 45% of all MBC patients of the region had been admitted to the study. Only 27% of these patients were treated at the university hospital indicating that 85% of all MBC patients of the region were treated outside university hospitals.(ABSTRACT TRUNCATED AT 250 WORDS)