title: On the value of response criteria in therapeutic research.
abstract: Primary chemotherapy is the use of anticancer drugs as the first treatment in patients with localized tumor presentations for which there is an alternative but less than satisfactory treatment. Its most important feature is the preservation of the primary tumor mass as a biologic marker of response, and in this sense it shares the same response criteria as induction chemotherapy for advanced cancer for which there is no alternative treatment. The use of chemotherapy as the primary treatment for patients with localized tumor presentations is experimental except in localized forms of tumors such as diffuse large-cell lymphomas, small-cell lung cancers, and some pediatric malignancies. Complete remission rates and relapse-free survival are the best current way of quantifying the cytoreductive effect of primary chemotherapy. The use of full dose chemotherapy together with a flexible number of induction cycles is recommended. Protocol design should not obscure these endpoints by adding alternative therapies before a best response to primary chemotherapy is attained.
authors.affiliation: National Cancer Institute, Bethesda, Maryland.
authors.forename: V T
authors.initials: VT
authors.lastname: Devita
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D004305:Dose-Response Relationship, Drug; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D012074:Remission Induction; D013997:Time Factors
chemical_list: D014408:Biomarkers, Tumor