Association between radiotherapy vs no radiotherapy based on early response to VAMP chemotherapy and survival among children with favorable-risk Hodgkin lymphoma.
BACKGROUND
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.


OBJECTIVE
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.


METHODS
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.


METHODS
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00145600.
Department of Oncology, St Jude Children's Research Hospital, and Health Sciences Center, University of Tennessee, Memphis, USA. monika.metzger@stjude.org
Monika L
ML
Metzger
Howard J
HJ
Weinstein
Melissa M
MM
Hudson
Amy L
AL
Billett
Eric C
EC
Larsen
Alison
A
Friedmann
Scott C
SC
Howard
Sarah S
SS
Donaldson
Matthew J
MJ
Krasin
Larry E
LE
Kun
Karen J
KJ
Marcus
Torunn I
TI
Yock
Nancy
N
Tarbell
Catherine A
CA
Billups
Jianrong
J
Wu
Michael P
MP
Link
D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D009325:Nausea / Q000139:chemically induced; D009437:Neuralgia / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D011241:Prednisone / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage; D014839:Vomiting / Q000139:chemically induced; D055815:Young Adult
D014747:Vinblastine; D004317:Doxorubicin; D011241:Prednisone; D008727:Methotrexate