Background: The present goal for the treatment of HL is to develop a combined modality therapy with high response rate, disease-free survival (DFS) and overall survival (OSV) with minimal toxicity.
Methods: On December 1996, the GATLA started a non randomized protocol for 15 to 75 years old (median 28) patients previously untreated. Patients with clinical stage I, II, IIIA without bulky tumor (< 10 cm mass or < 1/3 thoraxic diameter) (low risk) received 3 cycles of ABVD followed by IFRT 25 Gy to all node areas of more than 2 cm at diagnosis. A total of 46 out of 218 patients (21%) with low risk who failed to achieve complete remission (CR) after 3 cycles of ABVD were included as high risk completing 6 cycles of ABVD. Patients with clinical stage IIIB and IV or all other stages with bulky disease or persistance lymph nodes areas after 3rd cycle of ABVD (high risk) received 6 cycles of ABVD followed by IFRT 30 Gy to residual areas after the third cycle of ABVD or bulky areas at diagnosis. The dose of ABVD was the standard; Adriamycin 25 mg/m2, Bleomycin 10 IU/m2, Vinblastine 6 mg/m2 and Dacarbacine 375 mg/m2 all IV on day 1 and 15 of each 28 days cycles. Patients who achieved partial remission (PR) were salvage with other regimen mainly ESHAP x 3 cycles followed by high dose therapy with autograft rescue.
Results: A total of 171 (99%) out of 172 patients with low risk achieved CR. One 74 year old patient died of pneumonia after the third ABVD. A total of 187 (85%) of 219 patients with high-risk achieved CR, 25 PR, and 7 failed to respond (FR) (P<0,001). The estimate DFS at 60 months was 92% and 67% (P< 0.001), while the OS was 98% and 89% (P=0.004) for low and high risk respectivelly. Of the 25 patients with PR, all received second line therapy followed in 15 by an autograft. Twelve patients are in CR, 5 are in PR, 2 in progressive disease and 6 died. Of the seven who FR, four died of PD an three are alive with the disease. One patient developed a MDS/AML after relapsing from an autograft and 8 months after having been rescued with BEACOPP. Five other second cancer (1 ovary, 2 NHL, 1 lung, 1 colon) appeared after treatment, two died and 3 remain in CR of their HL. Using the IPI HL 165 patients (48%) have scored 0–1, 145 (43%) scored 2–3, and 30 (9%) scored 3–4. The rate of CR was 96%, 88% and 87% respectively (P<0.016). The EFS at 60 months was 89%, 72% and 55% respectively (P=0.004). The OSV was 98%, 89% and 86% (P=0.037).
Conclusions: We can conclude by saying that with risk-adapted therapy, 92% of the 391 patients achieved CR, with a CR + PR response of 98%. A total of 78% are event-free and 93% are alive at 60 months with remarkable low-toxicity.