SreeaveSixty previously untreated patients with high grade non-Hodgkimns lymphomas stages II-IV received cyclophosphamide 750mgm2 i.v., doxorubicin 50mgm2 i.v., and vincristine 2mg i.v. on day 1, prednisolone 100mg p.o. on days 1-5 and etoposide lOOmgm2 i.v. on days 3-5 (CHOP-VP16). After four courses an involved field irradiation with a total dose of 25 Gy was employed and followed by two additional courses of CHOP-VP16. The overall response rate was 93%. with 49 patients (82%) achieving a complete remission (CR). Seven patients had a partial response and four patients showed no response. During a median follow-up period of 55 months, 22 of the 49 patients with CR relapsed, seven of them achieving a second complete remission with the same drug regimen. A maintained complete remission of up to 68 months was seen in 55% of all patients initially achieving CR. The median survival is 43 months. Mean side-effects of this drug regimen were alopecia (89%), nausea/vomiting (76%) and leukopenia (61%). No therapy-related deaths were seen. The results of this study demonstrate that this combined modality treatment produces high complete remission rates and that more than half of these patients achieve long-term disease-free survival.
We observed no superior benefit for alternating regimens, and conclude that both are effective treatment protocols for aggressive histologic-type malignant lymphomas. The results obtained with four cycles of poly-chemotherapy followed by an involved field irradiation are comparable to programs using more aggressive and/or prolonged chemotherapy.
In a multicentre phase III trial 146 previously untreated patients with high grade non-Hodgkin's lymphomas stage II-IV were randomized to receive either four cycles of CHOEP (cyclophosphamide 750 mg/m2 iv d 1, doxorubicin 50 mg/m2 iv d 1, vincristine 2 mg iv d 1, etoposide 100 mg/m2 iv d 3-5, prednisolone 100 mg po d 1-5) (treatment arm A), or four cycles of chemotherapy with hCHOP (cyclophosphamide 1200 mg/m2 iv d 1, doxorubicin 40 mg/m2 iv d 1 + 2, vincristine 2 mg iv d 1, prednisolone 100 mg po d 1-5) alternating with IVEP (ifosfamide 1500 mg/m2 iv d 1-5, vindesine 3 mg/m2 iv d 1, etoposide 120 mg/m2 iv d 3-5, prednisolone 100 mg po d 1-5) (treatment arm B). After four cycles of chemotherapy an involved field irradiation with a total dose of 35 Gy was given to all patients in complete or partial remission without persisting extranodal disease. A complete response (CR) was seen in 124/146 patients (86 per cent) with 87 per cent CR in arm A versus 83 per cent CR in arm B. During a median follow-up of 17 months (range 2-40) 30 patients relapsed (16 patients arm A, 14 patients arm B). The overall survival at 40 months is projected to be 71 per cent versus 70 per cent for arm A and B, respectively. Disease-free survival is projected to be 68 per cent in arm A and 59 per cent in arm B at 40 months. So far, the differences in CR, survival and disease-free survival are not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)
185 patients with high grade non-Hodgkin’s lymphoma stages II-IV entered this multicentre trial and were randomized to receive either four cycles of CHOEP (cyclophosphamide 750mg/m2 i.v. d 1, dox-orubicin 50 mg/m2 i.v. d 1, vincristine 2 mg i.v. d 1, etoposide 100 mg/ m2 i.v. d 3–5, prednisolone 100 mg p.o. d 1–5) (treatment arm A), or four cycles of chemotherapy with hCHOP (cyclophosphamide 1,200 mg/m2 i.v. d 1, doxorubicin 40 mg/m2 i.v. d 1 + 2, vincristine 2mg i.v. d 1, prednisolone 100 mg p.o. d 1–5) alternating with IVEP (ifosfamide 1,500 mg/m2 i.v. d 1–5, vindesine 3 mg/m2 i.v. d 1, etoposide 120mg/m2 i.v. d 3–5, prednisolone 100mg p.o. d 1–5) in treatment arm B. After four cycles of chemotherapy an involved field irradiation with a total dose of 35 Gy was given to all patients demonstrated to be in complete or partial remission without persisting extranodal disease. So far, 146 patients have completed treatment and are evaluable for response and survival. A complete response (CR) was seen in 124/146 patients (86%) with 89% CR in arm A vs. 83% CR in arm B. During a median follow-up of 17 months (range 2–40) 30 patients relapsed (16 pts. arm A, 14 pts. arm B). The overall survival at 40 months is projected to be 70% vs. 71 % for arm A and B, respectively. Disease-free survival is projected to be 68% in arm A and 59% in arm B at 40 months. So far, the differences in CR, survival and disease-free survival are not statistically significant. Toxicity of all regimens was acceptable, however, with a significant morbidity and one treatment-related death in patients > 70 years after hCHOP. Main side effects were mild nausea/vomiting, leukopenia and fever/infection associated with leukopenia. In conclusion, both treatment modalities produced high complete remission rates. A longer follow-up will be needed to exclude differences in overall and disease-free survival.
In einer multizentrischen Studie wurden 46 nicht vorbehandelte Patienten mit hochmalignen Non-Hodgkin-Lymphomen der Stadien II-IV mit 6 Zyklen einer Chemotherapie, bestehend aus Endoxan 750 mg/m2 i. v. Tag 1 Adriamycin 50 mg/m2 i. v. Tag 1 Vincristin 2 mg i. v. Tag 1 Prednison 100 mg p. o. Tag 1–5 und Etoposid 100 mg/m2 i. v. Tag 3–5, behandelt. Zusätzlich wurde zwischen dem 4. und 5. Zyklus eine Involved-field-Bestrahlung mit 25 Gy durchgeführt. Die Gesamt-ansprechrate war 91 %. 38 Patienten erreichten eine komplette Remission (82%), 4 Patienten eine partielle Remission (9%), und 4 Patienten zeigten kein Ansprechen (9 %). Während einer medianen Nachbe-obachtungszeit von 34 Monaten hatten 16 von 38 Patienten mit CR ein Rezidiv, von denen sich 4 durch erneute CHOPV-Therapie wieder in eine CR überführen ließen. 51% der Patienten mit CR zeigen eine anhaltende CR bis zu 52 Monaten. Die Überlebenskurve aller Patienten zeigt eine Plateaubildung bei 60% nach 30 Monaten und die Überlebenskurve der rezidivfreien Patienten eine Plateaubildung bei 51 % nach 36 Monaten. Die Therapienebenwirkungen bestanden vor-wiegend in Alopezie (89%), Übelkeit/Erbrechen (76%) und Leu-kopenie (61%). Therapiebedingte Todesfälle traten nicht auf. Die Ergebnisse der Studie zeigen, daß diese Therapieform in der Lage ist, hohe CR-Raten zu induzieren, von denen der größte Teil von anhal-tender Dauer ist und damit eine potentielle Heilung bedeuten kann.
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