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)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3551-3551 ◽  
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.

First-line treatment with single agent rituximab, followed by maintenance rituximab plus anti-idiotype Id-KLH active immunotherapy vaccine (FavId) in patients (pts) with low-grade non-Hodgkin lymphoma (NHL): Preliminary results of a phase II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8080-8080 ◽  
Author(s):  
E. Raefsky ◽  
F. A. Greco ◽  
D. R. Spigel ◽  
S. Litchy ◽  
V. Gian ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Single Agent ◽  
Active Immunotherapy ◽  
Low Grade ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

8080 Background: Single agent rituximab produces a high response rate when used as first-line treatment, and maintenance rituximab prolongs remission duration. Active immunotherapy is a promising treatment approach, when administered following remission induction by initial therapy. In this phase II trial, we evaluate the feasibility, toxicity, and efficacy of administering concurrent maintenance rituximab plus Id-KLH vaccine in pts with low-grade NHL. Methods: Pts with previously untreated low-grade NHL (grade 1/2 follicular or SLL) who were judged to be candidates for single agent rituximab therapy were eligible. All pts had initial biopsy for production of the Id-KLH vaccine. All pts received rituximab 375mg/m2 IV, weekly × 4. Pts with CR/CRu, PR, or stable disease at 8 weeks proceeded with maintenance rituximab (standard 4 week courses at 6 month intervals for 3 courses) and Id-KLH vaccination (Id-KLH 1cc day 1; GMCSF 250μg SQ days 1–4) monthly × 8, beginning month 3, then every 2 months during the second year. Pts were monitored for response rate, progression- free survival, and toxicity. Results: To date, 36 of a planned 56 pts have been enrolled. Idiotype vaccine was successfully manufactured in 27 of 32 pts (84%), with 4 in production. Of the 27 pts for whom Id-KLH was successfully manufactured, 2 progressed during rituximab. 19 of 25 pts (14FL;5SLL) have had response determined after rituximab: 8 PR (42%), 11 stable (58%; 4 of 5 SLL). Pts have now received rituximab maintenance therapy plus Id-KLH for durations of 6 - 34 months. 6 of 19 pts (3 SLL) progressed at months 5, 6, 9, 9, 10, and 12, respectively. Treatment has been well tolerated, with no unusual toxicities observed. Rituximab-related hypotension and atrial fibrillation occurred in 1 pt. The most common Id-KLH related adverse event has been injection site reaction. Conclusions: Concurrent maintenance therapy with rituximab plus Id-KLH is safe and well tolerated. At present, 6 of 25 pts (24%) have progressed (including 3 of the 5 SLL pts) with a median followup of 19 months. This trial is continuing. No significant financial relationships to disclose.

Comparison of efficacy and safety of first-line palliative chemotherapy with TX and XELOX regimens in patients with metastatic gastric adenocarcinoma: A randomized phase II trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4070-4070
Author(s):  
Xiaodong Zhu ◽  
Jin Li ◽  
Zhao Xiaoying ◽  
Weijian Guo ◽  
Xin Liu ◽  
...  
Keyword(s):  
Survival Time ◽  
Phase Ii ◽  
Predictive Factors ◽  
Palliative Chemotherapy ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Line Treatment ◽  
First Line ◽  
Genomics And Proteomics ◽  
First Line Treatment

4070 Background: Docetaxel has shown antitumor activity in the treatment of MGC as a single or combination chemotherapy. This study was designed to compare the clinical outcome of docetaxel based and platinum based doublet regimen as first-line treatment in MGC patients. Methods: In an open, randomized, single center phase II trial, 134 pts were randomly assigned and treated with either TX (capecitabine 1g/m2/twice daily/ 1-14 days and docetaxel 75mg/m2 in 1st day) or XELOX (capecitabine 1g/m2/twice daily/ 1-14 days and oxaliplatin 130 mg/m2 in 1st day) as first-line chemotherapy. The primary endpoint is finding potential predictive factors, secondary endpoint is ORR, PFS, OS and safety. After progression, patients were switched into the other group. Results: Now, the potential predictive factors are testing in genomics and proteomics. In 134 randomly assigned and treated pts (TX = 69; XELOX = 65). Most pts were male (87pts).Overall survival was longer with TX versus XELOX (13.1m vs. 9.6m, p = 0.173), but no statistical differences. Progression free survival was similar with TX versus XELOX (4.57m vs. 5.27m, p = 0.297). Overall response rate was equal with TX versus XELOX (50.8% vs. 47.6%, p = 0.72). G3-4 treatment-related AE occurred in 60.6% (TX) v 55.4% (XELOX) of patients. Frequent G3-4 toxicities for TX v XELOX were: neutropenia (60.6% v 15.4%), febrile granulocyte deficiency (17.4% v 1.5%), anemia (10.1% v 10.8%), thrombocytopenia (1.4% v 15.4%), and all grade peripheral neurotoxicity (11.6% v 38.5%).After first-line treatment failure, 35 patients in the TX group switched to XELOX, and 27 patients in the XELOX group switched to TX, and there is also no significant difference in survival time from the first-line treatment between the two groups (p = 0.129). Conclusions: Although TX led to more neutropenia, first-line palliative chemotherapy with docetaxel based doublet regimens provides a new choice and can gain almost the same response rate and survival time as frequently-used fluorouracil and platinum based regimen. And potential predictive factors will indicate who will get more benefit from taxanes or platinums. Clinical trial information: NCT01963702.

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

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.

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 ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3691-3691 ◽  
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.

Phase II study of infusional 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus bevacizumab as first-line treatment for metastatic colorectal cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4089-4089 ◽  
Author(s):  
S. Kopetz ◽  
K. Y. Glover ◽  
C. Eng ◽  
R. A. Wolff ◽  
D. Z. Chang ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Performance Status ◽  
Progression Free Survival ◽  
Line Treatment ◽  
First Line ◽  
Intention To Treat ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
First Line Treatment

4089 Background: When compared to bolus 5-fluorouracil (F), leucovorin (L), and irinotecan (I) regimens such as IFL, the infusional F, L, I regimen (FOLFIRI) resulted in a improved toxicity profile with a response rate (RR) of 35% and median progression free survival (PFS) of 6.7 months. When combined with bevacizumab (B) as first-line treatment, IFL demonstrated improved activity with a RR of 45% and a median PFS of 10.6 months. Combining FOLFIRI and B may further improve the efficacy. Methods: We designed a single-arm, phase II trial of FOLFIRI+B with B (5mg/kg), I (180mg/m2), bolus of F (400mg/m2) and L (400mg/m2) with a 46-hour infusion of F (2400mg/m2) every 2 weeks. The primary endpoint was PFS. Chemotherapy naïve mCRC patients (pts) with a performance status of 0–2 received B alone on Day -14, starting FOLFIRI+B on Day 1. Proteomic and radiographic correlative studies were completed and will be reported separately. Results: N=41 pts, median age 56 y/o (range 26–78), M:F = 16:25, 5 pts with prior adjuvant therapy, were enrolled from 1/2005 to 1/2007. A total of 502 cycles have been administered (median = 12). The median PFS is 12.6 months. Response rate by intention-to-treat analysis was 62% (24 pts), with 33% stable disease (13 pts). Responses occurred after a median of 4 months of therapy. Fifteen pts remain on treatment; 26 pts are off study: 7 for progressive disease, 2 withdrew consent, 7 for toxicity and 2 for surgery unrelated to cancer. Eight pts were removed from the study for metastasectomies. Grade 3 or 4 toxicities included 17 occurrences of grade = 3 neutropenia, including 1 grade 4 febrile neutropenia, 4 grade 4 pulmonary emboli, 2 grade 3 hand-foot syndrome, and 1 grade 3 diarrhea. One pt included in the analysis developed a possible microperforation, manifested by peritonitis, after B alone and never received FOLFIRI. Conclusion: FOLFIRI+B is well-tolerated and efficacious, with an impressive PFS that compares favorably to historical controls. This regimen is an excellent choice as a first-line treatment for mCRC. No significant financial relationships to disclose.

scholarly journals Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study)

2021 ◽  
Vol 13 ◽  
pp. 175883592110619
Author(s):  
Sung-Bae Kim ◽  
Jae Hong Seo ◽  
Jin-Hee Ahn ◽  
Tae-Yong Kim ◽  
Seok Yun Kang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Triple Negative ◽  
Response Rate ◽  
Phase Ii Study ◽  
Objective Response ◽  
Line Treatment ◽  
First Line ◽  
Grade 3 ◽  
First Line Treatment

Background: Standard intravenous (IV) paclitaxel is associated with hypersensitivity/toxicity. Alternative IV formulations have improved tolerability but still require frequent hospital visits and IV infusion. DHP107 is a novel oral formulation of paclitaxel that is approved in South Korea for the treatment of gastric cancer. Methods: This multicenter, phase II study using a Simon’s two-stage design investigated the efficacy and safety of DHP107 200 mg/m2 administered orally twice daily on days 1, 8, and 15 every 4 weeks for the first-line treatment of recurrent or metastatic HER2-negative breast cancer. Results: Thirty-six patients were enrolled and 31 were assessable for efficacy. Patient median age was 57 years (range = 34–81) and 11 (31%) had triple-negative disease. A median of seven cycles (range = 1–28) of DHP107 was administered. Objective response rate was 55% (17 patients), all partial responses, according to the investigator’s decision and independent central review (ICR), and 44% (4/9 patients) in those with triple-negative disease. Disease control rate (partial response and stable disease) was 74% (23 patients) according to the investigator’s decision and ICR. In the intention-to-treat (ITT) population of all enrolled participants, the objective response rate was 50% (18/36 patients). Median progression-free survival was 8.9 months [95% confidence interval [CI]: 5.2–12.3) and median time to treatment failure was 8.0 months (95% CI: 4.2–10.0). DHP107 had an acceptable toxicity profile. All patients experienced treatment-emergent adverse events; the most common adverse events were decreased neutrophil count (81% all grades and 78% grade ⩾ 3) followed by peripheral sensory neuropathy (61% all grades and 8% grade 3). However, there was no febrile neutropenia or sepsis. Conclusion: DHP107 showed promising efficacy and acceptable tolerability in this phase II study and is currently being investigated in the OPTIMAL phase III study (NCT03315364). Trial registration: This trial was registered with ClinicalTrials.gov identifier: NCT03315364.

Gemcitabine combined with cisplatin as first-line treatment in patients 60 years or older with epithelial ovarian cancer: a phase II study

2003 ◽  
Vol 13 (2) ◽  
pp. 130-137 ◽  
Author(s):  
T. Bauknecht ◽  
A. Hefti ◽  
G. Morack ◽  
C. Villena-Heinsen ◽  
D. Wallwiener ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Line Treatment ◽  
First Line ◽  
Stage Iiic ◽  
Grade 3 ◽  
First Line Treatment

This phase II study evaluated the activity and toxicity of gemcitabine plus cisplatin as first-line treatment of patients with advanced ovarian cancer. Chemonaive patients ≥60-year-old with FIGO stage IIIC or IV epithelial ovarian carcinoma were enrolled. Patients received cisplatin 75 mg/m2 on day 1 and gemcitabine 1250 mg/m2 on day 1 (before cisplatin) and day 8 of a 21-day cycle. Of 44 female patients (median age, 70 years), 72.7% had stage IIIC disease and 67.4% had a Karnofsky performance status ≥80. Of the 37 response-evaluable patients (35 with measurable lesion[s] ≥2 cm), there were seven (18.9%) pathologic complete responses, two (5.4%) pathologic partial responses, two (5.4%) clinical complete responses, and 12 (32.4%) clinical partial responses, for an overall response rate of 62.2% (95% CI, 44.8%–77.5%), and a pathologic response rate of 24.3% (95% CI, 11.8%–41.2%). Median survival was 27.7 months (95% CI, 14.3–40.8 months). Grade 3/4 neutropenia and thrombocytopenia occurred in 59.5% and 30.2% of patients, respectively, with neutropenic fever in one patient. Grade 3 nausea /vomiting and alopecia occurred in 25.6% and 9.5% of patients, respectively. We conclude that gemcitabine plus cisplatin is active and feasible as first-line treatment of advanced epithelial ovarian cancer in patients ≥60 years. Further clinical trials adding gemcitabine to current standard, first-line treatment seem warranted in younger as well as older patients.

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

2005 ◽  
Vol 23 (7) ◽  
pp. 1500-1506 ◽  
Author(s):  
John D. Hainsworth ◽  
Sharlene Litchy ◽  
Lisa H. Morrissey ◽  
Michael B. Andrews ◽  
Manuel Grimaldi ◽  
...  
Keyword(s):  
Short Duration ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Line Treatment ◽  
First Line ◽  
Short Course ◽  
Short Course Chemotherapy ◽  
Grade 3 ◽  
First Line Treatment

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.

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