Our results confirmed that an interim PET/CT scan has limited prognostic value in patients with diffuse large B-cell lymphoma homogeneously treated with six cycles of R-CHOP-14 in a large prospective trial. At this point, interim PET/CT scanning is not ready for clinical use to guide treatment decisions in individual patients.
Introduction: The EUROpean Bone Over 40 Sarcoma Study (EURO-B.O.S.S.) was the first prospective internationalstudy for patients 41-65 years old with high-grade bone sarcoma treated with an intensive chemotherapy regimen derived from protocols for younger patients with high-grade skeletal osteosarcoma. Methods: Chemotherapy based on doxorubicin, cisplatin, ifosfamide, and methotrexate was suggested, but patients treated with other regimens at the investigators' choice were also eligible for the study. Results: The present report focuses on the subgroup of 218 patients with primary high-grade osteosarcoma. With a median follow-up of 47 months, the 5-year probability of overall survival (OS) was 66% in patients with localized disease and 22% in case of synchronous metastases. The 5-year OS in patients with localized disease was 29% in pelvic tumors, and 70% and 73% for extremity or craniofacial locations, respectively. In primary chemotherapy, tumor necrosis ≥90% was reported in 21% of the patients. There were no toxic deaths; however, hematological toxicity was considerable with 32% of patients experiencing 1 or more episodes of neutropenic fever. The incidence of nephrotoxicity and neurotoxicity (mainly peripheral) was 28% and 24%, respectively. After methotrexate, 23% of patients experienced delayed excretion, in 4 cases with nephrotoxicity.
The feasibility and efficacy of a combination of thalidomide, cyclophosphamide, etoposide, and dexamethasone were studied in 56 patients with poor-prognosis multiple myeloma. Of 50 patients evaluable for response, 4% achieved complete response (CR), 64% partial response (PR), 18% minimal response (MR), 6% stable disease (SD), and 8% progressive disease (PD), resulting in an objective response rate (> MR) of 86.0% (76.7% overall objective response rate in intent-totreat analysis; n ؍ 56). Subsequent to successful remission induction, 18 patients received autologous or allogeneic stem cell transplantation. The median progression-free survival in all patients was 16 months. The median overall survival time could not be calculated, since the last observed death occurred after 16 months of follow-up (median follow-up of 14 months) with a corresponding estimated survival probability of 55%. Severe adverse effects (World Health Organization III/IV) included infectious complications (35.7%) and cardiovascular events (7.1%). The data suggest that Thal improves antitumor activity of salvage chemotherapy regimens in poor-prognosis multiple myeloma. IntroductionDespite modern treatment modalities, including high-dose chemotherapy with stem cell support, multiple myeloma (MM) remains incurable in most cases. The majority of patients suffer from recurrent disease and ultimately succumb to sequelae of this disease. [1][2][3][4] Allogeneic stem cell transplantation might induce longterm remission in some patients but is associated with relatively high morbidity and mortality. 2 The antimyeloma effect of thalidomide (Thal) alone has been demonstrated in several clinical trials. [5][6][7] Recent data indicate that Thal can increase the therapeutic effect of chemotherapy and might be able to overcome drug resistance. [8][9][10][11] We report our results of a clinical phase 2 trial using a combination of cyclophosphamide, etoposide, and dexamethasone simultaneously with Thal. The aim was to improve the outcome of patients with MM and we have observed a very high response rate in a group of patients with poor prognosis. Study designFifty-six patients with poor-prognosis MM were included in a phase 2 clinical protocol (thalidomide/cyclophosphamide/etoposide/dexamethasone [TCED] protocol; Table 1). The study protocol was approved by the institutional review board. Thal treatment (400 mg taken daily per os [po]) was continued until toxic side effects, progression, or another event occurred that led to the termination of the patient from the study. CED chemotherapy (400 mg/m 2 per day cyclophosphamide intravenously [iv] and 40 mg/m 2 per day etoposide iv, both as continuous infusion days 1-4; 40 mg dexamethasone po days 1-4; repeat after 28 days) was given for 3 to a maximum of 6 cycles until best response. Patients received daily antibiotic prophylaxis.To reduce the number of leukopenic days after chemotherapy, subcutaneous administration of granulocyte colony-stimulating factor (G-CSF; Amgen, Thousand Oaks, CA) was recommended in ...
The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.
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