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Association Between Radiotherapy vs No Radiotherapy Based on Early Response to VAMP Chemotherapy and Survival Among Children With Favorable-Risk Hodgkin Lymphoma
- Source :
- JAMA. 307
- Publication Year :
- 2012
- Publisher :
- American Medical Association (AMA), 2012.
-
Abstract
- More than 90% of children with favorable-risk Hodgkin lymphoma can achieve long-term survival, yet many will experience toxic effects from radiation therapy. Pediatric oncologists strive for maintaining excellent cure rates while minimizing toxic effects.To evaluate the efficacy of 4 cycles of vinblastine, Adriamycin (doxorubicin), methotrexate, and prednisone (VAMP) in patients with favorable-risk Hodgkin lymphoma who achieve a complete response after 2 cycles and do not receive radiotherapy.Multi-institutional, unblinded, nonrandomized single group phase 2 clinical trial to assess the need for radiotherapy based on early response to chemotherapy. Eighty-eight eligible patients with Hodgkin lymphoma stage I and II (3 nodal sites, no B symptoms, mediastinal bulk, or extranodal extension) enrolled between March 3, 2000, and December 9, 2008. Follow-up data are current to March 12, 2012.The 47 patients who achieved a complete response after 2 cycles received no radiotherapy, and the 41 with less than a complete response were given 25.5 Gy-involved-field radiotherapy.Two-year event-free survival was the primary outcome measure. A 2-year event-free survival of greater than 90% was desired, and 80% was considered to be unacceptably low.Two-year event-free survival was 90.8% (95% CI, 84.7%-96.9%). For patients who did not require radiotherapy, it was 89.4% (95% CI, 80.8%-98.0%) compared with 92.5% (95% CI, 84.5%-100%) for those who did (P = .61). Most common acute adverse effects were neuropathic pain (2% of patients), nausea or vomiting (3% of patients), neutropenia (32% of cycles), and febrile neutropenia (2% of patients). Nine patients (10%) were hospitalized 11 times (3% of cycles) for febrile neutropenia or nonneutropenic infection. Long-term adverse effects after radiotherapy were asymptomatic compensated hypothyroidism in 9 patients (10%), osteonecrosis and moderate osteopenia in 2 patients each (2%), subclinical pulmonary dysfunction in 12 patients (14%), and asymptomatic left ventricular dysfunction in 4 patients (5%). No second malignant neoplasms were observed.Among patients with favorable-risk Hodgkin lymphoma and a complete early response to chemotherapy, the use of limited radiotherapy resulted in a high rate of 2-year event-free survival.clinicaltrials.gov Identifier: NCT00145600.
- Subjects :
- Male
medicine.medical_specialty
Neutropenia
Adolescent
Vomiting
medicine.medical_treatment
Vinblastine
Asymptomatic
Disease-Free Survival
Young Adult
Prednisone
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Child
Chemotherapy
business.industry
Nausea
General Medicine
medicine.disease
Hodgkin Disease
Chemotherapy regimen
Surgery
Radiation therapy
Methotrexate
Treatment Outcome
Doxorubicin
Child, Preschool
Neuralgia
Female
medicine.symptom
business
Febrile neutropenia
medicine.drug
Subjects
Details
- ISSN :
- 00987484
- Volume :
- 307
- Database :
- OpenAIRE
- Journal :
- JAMA
- Accession number :
- edsair.doi.dedup.....4d3459850790ffbcc13ef37f943521ac