Violations of chemotherapy protocols for ovarian cancer--reasons and consequences

In times when colony-stimulating factors were not available, delays of treatment or dose reductions were necessary, to assure that chemotherapy could be safely administered. In a retrospective analysis the effects of chemotherapy protocol violations on the survival of patients with ovarian cancer was evaluated. The serial courses of leukocyte counts were often the determinants for a protocol adequate chemotherapy in contrary to the thrombocytes but the serial platelet counts had no influence on protocol violations. Only time-related protocol violations have been found in 7.6% of the cases. There seems to be no apparent influence on patients' survival. However, accomplishment of treatment schedules, which may be regarded as a reaction towards unsatisfactory tumour response, at the initial visit alone or in combination with time-related protocol violations as well as tumour stage, course of tumour markers (CA 125) had a strong impact on survival while higher dosage levels produces only a trend towards improved survival. The use of growth factors will probably reduce the percentage of protocol violations caused by neutropenia, but it is questionable if it will reduce mortality due to tumour progression.