Joint Final Report of EORTC 26951 and RTOG 9402: Phase III Trials With Procarbazine, Lomustine, and Vincristine Chemotherapy for Anaplastic Oligodendroglial Tumors.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the basis of the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. Anaplastic oligodendroglial tumors (AOTs) are chemotherapy-sensitive brain tumors. We report the final very long-term survival results from European Organization for the Research and Treatment of Cancer 26951 and Radiation Therapy Oncology Group 9402 phase III trials initiated in 1990s, which both studied radiotherapy with/without neo/adjuvant procarbazine, lomustine, and vincristine (PCV) for newly diagnosed anaplastic oligodendroglial tumors. The median follow-up duration in both was 18-19 years. For European Organization for the Research and Treatment of Cancer 26951, median, 14-year, and probable 20-year overall survival rates without versus with PCV were 2.6 years, 13.4%, and 10.1% versus 3.5 years, 25.1%, and 16.8% (N = 368 overall; hazard ratio [HR] 0.78; 95% CI, 0.63 to 0.98; P = .033), with 1p19q codeletion 9.3 years, 26.2%, and 13.6% versus 14.2 years, 51.0%, and 37.1% (n = 80; HR 0.60; 95% CI, 0.35 to 1.03; P = .063), respectively. For Radiation Therapy Oncology Group 9402, analogous results were 4.8 years, 16.5%, and 11.2% versus 4.8 years, 29.1%, and 24.6% (N = 289 overall; HR 0.79; 95% CI, 0.61 to 1.03; P = .08), with codeletion 7.3 years, 25.0%, and 14.9% versus 13.2 years, 46.1%, and 37% (n = 125; HR 0.61; 95% CI, 0.40 to 0.94; P = .02), respectively. With that, the studies show similar long-term survival even without tumor recurrence in a significant proportion of patients after first-line treatment with radiotherapy/PCV.
Competing Interests: Andrew B. LassmanConsulting or Advisory Role: Karyopharm Therapeutics, Sapience Therapeutics, Bayer, Orbus Therapeutics, BioClinica, Novocure, Elsevier, Vivacitas Oncology, ChimerixResearch Funding: AbbVie (Inst), Novartis (Inst), Genentech/Roche (Inst), Aeterna Zentaris (Inst), Kadmon (Inst), BeiGene (Inst), VBI Vaccines (Inst), Pfizer (Inst), Millennium (Inst), Karyopharm Therapeutics (Inst), Bayer (Inst), QED Therapeutics (Inst), Orbus Therapeutics (Inst), BMS (Inst), Chimerix (Inst), NextSource (Inst), DelMar Pharmaceuticals (Inst), Corden (Inst), Kazia Therapeutics (Inst), Servier (Inst), Semus (Inst), Novocure (Inst)Travel, Accommodations, Expenses: Karyopharm Therapeutics, QED Therapeutics, Novartis, Pfizer, VBI Vaccines, Chimerix, Orbus Therapeutics, Novocure Khê Hoang-XuanHonoraria: BTG J. Gregory CairncrossOther Relationship: IQVIA Lynn S. AshbyHonoraria: Arbor Pharmaceuticals Luis SouhamiHonoraria: Varian Medical SystemsConsulting or Advisory Role: AbbVieResearch Funding: Sanofi (Inst)Travel, Accommodations, Expenses: Varian Medical Systems Winand N.M. DinjensConsulting or Advisory Role: Bristol Myers Squibb, Roche, Bayer, AstraZeneca, Novartis, LillySpeakers' Bureau: medtlks Nadia N. LaackResearch Funding: Bristol Myers Squib (Inst) Karen L. FinkResearch Funding: Northwest Biotherapeutics (Inst), Novocure (Inst), Orbus Therapeutics (Inst), Denovo Biopharma (Inst), Translational Genomics Research Institute (Inst), CNS Pharmaceuticals (Inst), Agios (Inst), Incyte (Inst) Pim J. FrenchEmployment: Bristol Myers Squibb (I), Janssen-Cilag (I)Stock and Other Ownership Interests: Bristol Myers Squibb (I)Honoraria: AurikamedConsulting or Advisory Role: Clarionhealthcare David R. MacdonaldResearch Funding: Celgene (Inst), SERVIER (Inst). Minesh MehtaLeadership: OncoceuticsStock and Other Ownership Interests: ChimerixConsulting or Advisory Role: Karyopharm Therapeutics, Mevion Medical Systems, ZappRx, Sapience Therapeutics, XoftPatents, Royalties, Other Intellectual Property: WARF patent 14/934,27, Topical Vasoconstritor Preparations and Methods for Protecting Cells During Cancer Chemotherapy and RadiotherapyUncompensated Relationships: Xcision Medical SystemsUncompensated Relationships: ViewRay Martin J. van den BentEmployment: AstraZeneca (I)Consulting or Advisory Role: Boehringer Ingelheim, Bayer, carthera, Genenta Science, Nerviano Medical Sciences, Boston Pharmaceuticals, chimerix, AstraZenecaResearch Funding: AbbVie (Inst)No other potential conflicts of interest were reported.