Rituximab Plus Short-Duration Chemotherapy As First-Line Treatment for Follicular Non-Hodgkin’s Lymphoma: A Phase II Trial of the Minnie Pearl Cancer Research Network

Purpose To evaluate the feasibility and efficacy of rituximab with short-duration chemotherapy in the first-line treatment of patients with follicular non-Hodgkin’s lymphoma (NHL). Patients and Methods Patients with previously untreated stage II-IV follicular NHL, grade 1 or 2, were eligible for this multicenter phase II trial. All patients received four weekly doses of rituximab (375 mg/m2 intravenous), followed by three courses of combination chemotherapy (either cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP], or cyclophosphamide, vincristine, and prednisone [CVP]) plus rituximab. Patients were evaluated for response after completing treatment, and were then followed up at 3-month intervals. Results Between January 2000 and July 2001, 86 patients were treated. Eight-two patients (95%) completed treatment; no patient was withdrawn due to toxicity. The overall response rate was 93%, with 55% complete responses. After a median follow-up of 42 months, the 3- and 4-year actuarial progression-free survivals were 71% and 62%, respectively. Five patients (6%) died from lymphoma; the overall actuarial survival at 3 years was 95%. Grade 3/4 leukopenia occurred in 53% of patients, but only six patients (7%) had neutropenia or fever. Grade 3/4 nonhematologic toxicities were uncommon. Conclusion Rituximab plus short-course chemotherapy is well tolerated as first-line treatment for patients with follicular NHL. The overall and complete response rates are similar to those reported with chemotherapy/rituximab combinations of longer duration. The actuarial progression-free survival of 62% at 4 years is encouraging, but further follow-up is necessary. Rituximab plus short-course chemotherapy may prove to be as effective as longer-duration chemotherapy and currently provides an attractive option for first-line treatment of elderly patients and others who tolerate chemotherapy poorly.

Download Full-text

The impact of cetuximab on the capecitabine plus oxaliplatin (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.3551 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 3551-3551 ◽

Cited By ~ 10

Author(s):

M. Borner ◽

W. Mingrone ◽

D. Koeberle ◽

R. Von Moos ◽

D. Rauch ◽

...

Keyword(s):

Phase Ii ◽

Response Rate ◽

Phase Ii Trial ◽

High Response ◽

Line Treatment ◽

First Line ◽

Clinical Cancer Research ◽

Grade 3 ◽

The Impact ◽

First Line Treatment

3551 Background: XELOX is a valuable alternative to continuous infusion FOLFOX type regimens in the treatment of MCC (Borner et al, JCO 2002, 1759). Cetuximab is an EGFR antibody, which has been shown to improve the efficacy of chemotherapy. A phase II study in first-line treatment of MCC has demonstrated a high response rate combining cetuximab with FOLFOX (Tabernero et al, Proc ASCO 2004, 3512). Methods: Multicenter, randomized two-arm phase II trial: OXA 130 mg/m2 day 1 and oral CAP 1000 mg/m2 bid days 1–14 every 21 days alone or in combination with cetuximab 250 mg/m2 weekly after a loading dose of 400 mg/m2. Treatment was limited to a maximum of 6 cycles. With 37 patients in each arm, the power was 90% to select the truly better arm if the true between-arm difference in response rate (RECIST) is at least 15%. The study was open for accrual until October 2005. Results: We present here the results of 74 patients included in the study. In 67 patients the first response data are available (investigators’ assessment after 3 cycles). The two arms are well balanced for relevant patient, disease and treatment characteristics. The study treatment was well tolerated with grade 3/4 toxicities in < 10% of the cycles in each arm. The frequency of side effects was balanced, but with more frequent skin toxicity in the cetuximab arm (6% versus 0% grade 3/4). Conclusions: Cetuximab seems to positively interact with XELOX in terms of efficacy but not toxicity. The cetuximab/XELOX combination appears to be a valuable option in first-line treatment of MCC especially if high response rates are a primary objective. This trial was supported in part by Merck KGaA and Sanofi-Aventis Switzerland. [Table: see text] No significant financial relationships to disclose.

Download Full-text

Phase II trial of modified FOLIRI plus Panitumumab as first-line treatment in elderly patients with RAS wild-type metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15053 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15053-e15053

Author(s):

Athanasios Karampeazis ◽

Lampros Vamvakas ◽

Nikolaos K. Kentepozidis ◽

Athanasios Kotsakis ◽

Kostas Kalbakis ◽

...

Keyword(s):

Colorectal Cancer ◽

Elderly Patients ◽

Metastatic Colorectal Cancer ◽

Phase Ii ◽

Phase Ii Trial ◽

Line Treatment ◽

Wild Type ◽

First Line ◽

Grade 3 ◽

First Line Treatment

e15053 Background:The role of combination chemotherapy plus anti-EGFR treatment in older patients with metastatic colorectal cancer (mCRC) is unclear. We conducted an open label phase II trial in order to evaluate the safety and efficacy of modified FOLFIRI plus panitumumab as first-line treatment in elderly patients with RAS wild-type mCRC. Methods: Patients ≥70 years old with unresectable all-RAS wild-type mCRC were treated with Panitumumab 6mg/kg as 60min iv infusion followed by Irinotecan 130mg/m2 as 90min iv infusion, Leucovorin 400mg/m2 as 2h iv infusion and 5-Fluorouracil 400mg/m2 as bolus iv infusion on day 1 and 5-Fluorouracil 1.200 mg/m2 as continuous iv infusion for 46h, every 2 weeks. Sample size calculation was based on the minimax Simon two-step design: The null hypothesis was that the overall response rate (ORR) is ≤ 30% versus the alternative hypothesis of ORR ≥ 50% (α = 0.05, power 80%). Results: Forty-six patients were enrolled in the study. Two patients did not receive treatment because they were RAS mutant. Median age for the 44 treated patients was 76 years (range 70-88). Males were 32 and the PS was 0, 1 and 2 in 25%, 70.5% and 4.5% of patients, respectively. Rectal cancer accounted for 25% while 15.9% of patients had the primary tumour in situ. Twenty-one partial responses were observed for an ORR of 47.7% (95%CI: 32.9%-62.5%) while seven patients (15.9%) had stable disease. After a median follow-up of 36.0 months, the median progression-free survival was 6.1 months (95%CI: 3.6-8.7) and the median overall survival was 20.9 months (95%CI: 11.7-30.1). Grade 3-4 neutropenia was recorded in 4 (9%) and grade 3-4 diarrhea in 9 (20.4%) patients while one patient had a grade 4 bowel perforation. One patient experienced grade 3 mucositis, two patients grade 3 skin toxicity and two patients grade 3 fatigue. There were no toxic deaths while one patient died due to bowel obstruction and one due to postoperative complications after removal of the primary tumor. Conclusions: The modified FOLFIRI plus panitumumab combination presented significant efficacy with manageable toxicity in elderly patients with mCRC.

Download Full-text

Final Results of a Multicenter Phase II Trial with Bendamustine and Rituximab As First Line Treatment for Patients with MALT Lymphoma (MALT-2008–01)

Blood ◽

10.1182/blood.v120.21.3691.3691 ◽

2012 ◽

Vol 120 (21) ◽

pp. 3691-3691 ◽

Cited By ~ 6

Author(s):

Antonio Salar ◽

Eva Domingo-Domenech ◽

Carlos Panizo ◽

Concepción Nicolás ◽

Joan Bargay ◽

...

Keyword(s):

Febrile Neutropenia ◽

Phase Ii ◽

Malt Lymphoma ◽

Phase Ii Trial ◽

Gastric Malt Lymphoma ◽

Line Treatment ◽

First Line ◽

Ann Arbor ◽

Grade 3 ◽

First Line Treatment

Abstract Abstract 3691 Background. There is currently no established treatment for the management of MALT lymphoma requiring systemic treatment. For patients failing to antibiotics or those with local advanced, refractory or disseminated disease several chemotherapy treatments have been studied. Considering the activity of Bendamustine in relapsed/refractory indolent lymphomas, with or without anti-CD20 antibodies, immunochemotherapy with Bendamustine plus Rituximab (BR) seems very attractive as first-line treatment for MALT lymphoma. Patients and methods. A nation-wide prospective phase II trial (EUDRACT 2008–007725–39) has been carried out in Spain by the GELTAMO group in untreated patients with CD20-positive MALT lymphoma. Patients with lymphoma arisen at any extranodal site and of any stage (Ann Arbor I-IV) could be enrolled. In addition, localized gastric MALT lymphoma previously refractory to H. pylori eradication or those with skin lymphoma not suitable for local therapy or previously treated with selective radiotherapy/surgery were also eligible. Treatment consisted of Bendamustine (90 mg/m2 d1–2) and Rituximab (375 mg/m2 d1), every 28 d. Pts were evaluated after completing 3 cycles: if complete remission (CR), pts received a further cycle (total of 4) and if partial response (PR), pts received 3 more cycles (total of 6). The aims were: feasibility and security of the combination and rate and quality of the responses, and event free survival. From May 2009 to May 2010, 60 patients were enrolled. Clinical characteristics: median age 62 years (range, 26–84); 34 (57%) female; Ann Arbor stage: I in 49%, II in 17% and III-IV in 34%; B-symptoms 5%. 20 patients (33%) had the lymphoma in the stomach, 35 (58%) in extra-gastric sites and the remaining 5 cases (8%) lymphoma was multifocal. The most common extra-gastric sites were lung and ocular adnexa in 11 and 7 patients, respectively. Results. A total of 264 cycles of BR were delivered in the whole population. Only 2 patients received less than 4 cycles. Rituximab dose was no modified at any cycle and only 5 patients required dose reduction of Bendamustine (median dose intensity: 0.98). Only 2 patients have not completed treatment due to toxicity: 1 case after 2 cycles due to severe rituximab-associated toxicity and another one after grade 4 febrile neutropenia in the 5th cycle. Grade 3–4 neutropenia was seen in 18% of patients. A total of 25 grade 3–4 non-haematologic toxicities were documented in 12 patients. Of note, 11 of these episodes were infectious (2 febrile neutropenia, 2 cytomegalovirus enteritis and 7 other).Response after 3 cycles of R was evaluable in 58 patients: 44 achieved CR or uCR and 14 patients PR, for an overall response rate (ORR) of 100% with a CR rate of 76%. CR rate after 3 cycles was higher in patients with gastric origin in comparison with non-gastric (90% vs 64%) (multifocal cases 100%). At the end of treatment, ORR was 100% with CR/uCR of 98%. A remarkable finding was that only 14 pts (23%) required more than 4 cycles of BR. With a median follow-up of 16 months (range, 3–40), one death has been recorded due to a neurologic syndrome and none patient has relapsed. Conclusions. The combination of Bendamustine and Rituximab in first line treatment of MALT lymphoma achieved an ORR of 100% after only 3 cycles. CR rate after completing treatment plan was 98%. Interestingly, a large majority of patients (85%) required only 4 cycles of treatment. This regimen was safe and well accepted by patients, making this response-adapted schedule a foremost therapeutic strategy for this type of lymphoma. Disclosures: Off Label Use: Bendamustine and rituximab are not currently approved for MALT lymphoma in first line, although both are commonly used in the relapse setting.

Download Full-text