As reported in the Journal of Clinical Oncology by Ann S. LaCasce, MD, MMSc, and colleagues, the phase II CALGB 50801/Alliance trial has shown that a positron-emission tomography (PET)-adapted treatment strategy allowed many patients with bulky stage I/II classical Hodgkin lymphoma to avoid radiotherapy and intensified chemotherapy, with no adverse effect on outcomes.
Ann S. LaCasce, MD, MMSc
Study Details
In the U.S. multicenter trial, 94 evaluable patients with bulky (mass > 10 cm or one-third of the maximum intrathoracic diameter on chest x-ray) early-stage classical Hodgkin lymphoma were enrolled between May 2010 and October 2017. Patients received two cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) followed by interim fluorodeoxyglucose PET (PET2). Those with PET2-negative disease received four additional cycles of ABVD; those with PET2-positive disease received four cycles of escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) followed by involved-field radiation therapy at 30.6 Gy. The primary endpoint was 3-year progression-free survival.
Progression-Free Survival
Among the 94 evaluable patients, 73 (78%) were PET2-negative and 21 (22%) were PET2-positive.
Median follow-up was 60 months. Progression-free survival at 3 years was 93.1% (95% confidence interval [CI] = 87.4%–99.1%) among PET2-negative patients and 89.7% (95% CI = 77.2%–100%) among PET2-positive patients. The hazard ratio for PET2-positive vs PET2-negative patients was 1.03 (85% CI upper bound of 2.38, significantly less than the null hypothesis of 4.1; P = .04). Among all patients, 3-year progression-free survival was 92.3% (95% CI = 87.0%–98.0%). Overall survival at 3 years was 98.6% (95% CI = 95.9%–100%) among PET2-negative patients and 94.4% (95% CI = 84.4%–100%) among PET2-positive patients.
KEY POINTS
- A PET-adapted approach allowed most patients to avoid radiotherapy and intensified chemotherapy.
- Progression-free survival at 3 years was 93.1% among PET2-negative patients and 89.7% among PET2-positive patients.
Adverse Events
Grade 3 or 4 adverse events were predominantly hematologic; neutropenia was the most common, occurring in 86% of both PET2-negative and PET2-positive patents. Grade 3 febrile neutropenia occurred in 9% of patients overall (8% and 10%) and grade 3 sepsis occurred in one patient. No grade 5 adverse events were reported. Among PET2-positive patients, no grade 4 pulmonary toxicity was observed; grade 3 toxicity consisted of two cases of dyspnea and one case each of pneumonitis and hypoxia.
The investigators concluded, “Our study of PET-adapted therapy in bulky stage I/II classical Hodgkin lymphoma met its primary goal and was associated with an excellent 3-year progression-free survival rate of 92.3% in all patients, with the majority being spared radiotherapy and exposure to intensified chemotherapy.”
Dr. LaCasce, of Dana-Farber Cancer Institute, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.