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82: Annals of Oncology 14:655-656, 2003
High international prognostic score predicts a worse outcome for patients with Hodgkin’s disease and HIV infection: results of a prospective study with Stanford V regimen
M. Spina1, A. Re2, E. Vaccher1, J. Gabarre3 and U. Tirelli11 Division of Medical Oncology A, National Cancer Institute, Aviano; 2 Department of Internal Medicine, Civil Hospital, Brescia, Italy; 3 Department of Hematology, Hospital Pitie-Salpetriere, Paris, France
Correspondence: *E-mail: oma@cro.it
Recently, Horning et al. reported the results of the Stanford V regimen in patients with locally extensive and advanced Hodgkin’s disease (HD) with a 5-year freedom from progression (FFP) of 89% and overall survival (OS) of 96%. The authors stated that the FFP was significantly superior among patients with an international prognostic score (IPS) of 0–2 compared with those with an IPS >=3.
Hodgkin’s disease in patients with HIV infection (HD–HIV) displays an unusually aggressive tumour behaviour, including a higher frequency of unfavourable histological subtypes and advanced stages, and poorer outcome compared with HD not accompanied by HIV infection. In May 1997, we started a prospective phase II study with the Stanford V regimen and radiotherapy in previously untreated HD–HIV patients with bulky limited stage or stage III–IV HD, with the aim of evaluating its efficacy according to IPS. This was the first prospective study aiming to evaluate IPS as a predictor of outcome in patients with HD–HIV.
Fifty-nine patients entered into the study. Fifty-one patients (86%) were males and the median age was 38 years (range 28–64). The distribution of HD histological subtypes was: mixed cellularity 46%, nodular sclerosis 30%, lymphocyte depletion 7%, not determined 17%. Stage III or IV disease was present in 42/59 (71%) patients, and 75% of patients had B symptoms. Forty-seven per cent of patients had extranodal involvement: 41% bone marrow, 39% spleen, 17% liver, 2% lung, 2% rectum and 2% adrenal gland.
With regard to IPS, 2/59 (3%) patients had an IPS of 0; 10 (17%) patients an IPS 1; 14 (24%) IPS 2; 14 (24%) IPS 3; seven (12%) IPS 4; 10 (17%) IPS 5; and 2/59 (3%) patients had an IPS of 6. Therefore, 33 (56%) patients had an IPS >2, whereas 26 (44%) had an IPS <=2. Forty-one (69%) patients completed the treatment without dose reduction or delay in chemotherapy administration. In 18 patients (31%) the dosage of all drugs except prednisone was reduced to 75% or less because of constipation (five cases), paresthesias (nine cases), bone marrow toxicity (three cases) or worsening of performance status (one case). In one patient who developed a life-threatening sepsis, Stanford V was discontinued. One toxic death was observed. No difference in the administration of chemotherapy or in toxic effects was recorded between the two groups, i.e. patients with IPS <=2 and patients with IPS >2.
Forty-eight out of 59 (81%) patients achieved a complete remission (CR) and five (8%) a partial remission, producing an overall response rate of 89%. The CR rate was significantly different between the two groups: 26/26 (100%) patients with IPS <=2 achieved a CR versus 22/33 (67%) patients with IPS >2 (P = 0.001).
In multivariate analysis, IPS >2 (hazard ratio 5.8, 95% confidence interval 1.0–33.4, P = 0.05) was the only parameter associated with significantly shorter survival. With a median follow-up of 17 months, the OS of patients with IPS >2 was significantly shorter than that of patients with IPS <=2 (23 months versus not reached, P = 0.004). Accordingly, the actuarial OS at 3 years of patients with IPS <=2 was 76% versus 33% of patients with IPS >2 (P = 0.001). Moreover, the actuarial FFP at 3 years was significantly superior among patients with IPS <=2 compared with those with IPS >2 (83% versus 52%, P = 0.02).
In conclusion, similarly to the observations of Horning et al. in general HD [1], we demonstrate for the first time in a prospective analysis that a high IPS predicts for significantly lower CR and OS rates in patients with HD–HIV treated with an intensive regimen, in this case Stanford V.
Acknowledgements
This study was supported by Associazione Italiana per la Ricerca sul Cancro and Istituto Superiore di Sanità grants.
M. Spina1, A. Re2, E. Vaccher1, J. Gabarre3 & U. Tirelli1*
1Division of Medical Oncology A, National Cancer Institute, Aviano; 2Department of Internal Medicine, Civil Hospital, Brescia, Italy; 3Department of Hematology, Hospital Pitie-Salpetriere, Paris, France (*E-mail: oma@cro