ROCHOP study: A phase III randomized study of CHOP compared to romidepsin-CHOP in untreated peripheral T-cell lymphoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS8616-TPS8616 ◽  
Author(s):  
Richard Delarue ◽  
Pier Luigi Zinzani ◽  
Mark S. Hertzberg ◽  
Won Seog Kim ◽  
Dolores Caballero ◽  
...  
Keyword(s):  
T Cell ◽  
Response Rate ◽  
Performance Status ◽  
Randomized Study ◽  
Total Duration ◽  
Progression Free Survival ◽  
Phase Iii ◽  
T Cell Lymphomas ◽  
Ann Arbor ◽  
Efficacy Parameters

TPS8616 Background: Peripheral T-cell lymphomas (PTCL) account for 10-15% of lymphomas. They share an aggressive clinical behaviour and a poor prognosis when treated by CHOP-like regimen which is nevertheless consider as a standard because others regimens failed to demonstrate survival advantage. Romidepsin is a histone deacetylase inhibitor with promising results in PTCL. First trials showed a response rate of 38% in heavily pre-treated PTCL patients. These results were confirmed with 15% of patients reaching a CR/CRu, 89% of them without disease progression at 13 months. Adverse events include gastrointestinal, hematologic and asthenic conditions. A phase I study of romidepsin combined with CHOP was conducted by LYSA. A total of 18 patients were included. The recommended dose was 12 mg/m² administered at day 1 and day 8 of each cycle. Methods: Ro-CHOP study is an international phase III study comparing 6 cycles of CHOP21 with 6 cycles of romidepsin-CHOP21 (EUDRACT 2012-001580-68). Primary endpoint is Progression-Free Survival assessed independently. Secondary objectives include overall survival, other efficacy parameters, analysis of response rate according to 18FDG-PET, safety, quality of life and biological ancillary studies. A total of 420 subjects aged from 18 to 80 years will be enrolled in the study. Main inclusion criteria are untreated PTCL whatever Ann Arbor stage and a performance status of 0-2. Main exclusion criteria are other subtypes of lymphoma, HTLV1 positivity, any cardiac abnormality, poor renal, hepatic and marrow functions unless related to lymphoma. Patients are randomized 1:1 between the two regimens. A stratification is performed with IPI score, age and histology. The first patient has been included in January 2013. A recruitment of 10.5 patients per month is anticipated, with a total duration of the study of 60 months. An update on enrolment will be presented at the meeting. Clinical trial information: 2012-001580-68.

Fluoxiuridine (FUDR) chronoinfusion and Interferon for treatment of metastatic renal carcinoma

1996 ◽  
Vol 63 (4) ◽  
pp. 458-461
Author(s):  
M. Dal Bianco ◽  
T. Prayer-Galetti ◽  
M. Iafrate ◽  
L. D'Urso ◽  
L. De Zorzi
Keyword(s):  
Objective Response Rate ◽  
Renal Carcinoma ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Randomized Study ◽  
Cell Cancer ◽  
Objective Response ◽  
Phase Iii ◽  
Major Side Effect

Fluoxiuridine (FUDR) chronoinfusion through a subcutaneous pump seems to give a 24% objective response rate with mild side effects. From April 1992 to December 1993 we included 18 patients with metastatic renal cell cancer and good performance status (ECOG 0-2) in a phase II study. In our experience we observed a 16% objective response rate without any major side effect. Based on these results we suggest a phase III prospective randomized study.

Effectiveness study of gemcitabine, oxaliplatin, and capecitabine as first-line treatment for nonresectable biliary tract cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 334-334
Author(s):  
Lars Henrik Jensen ◽  
Anne Haahr Mellergaard ◽  
Dan Hoegdall ◽  
Ole Larsen
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
Pivotal Phase ◽  
Tract Cancer ◽  
Gemcitabine And Cisplatin

334 Background: Since 2010, the doublet gemcitabine and cisplatin has been standard first-line systemic treatment for non-resectable biliary tract cancer. In a phase I-II trial of the well-tolerated triplet of gemcitabine, oxaliplatin, and capecitabine, the median progression free survival (PFS) and overall survival (OS) were 6.9 and 12.5 months, respectively. Overall response rate was 34%. Since 2005 the regimen has been used in Denmark. We wanted to investigate the effectiveness of the triplet regimen given in daily clinic. Methods: We included 192 patients from two institutions. Patients had to have non-resectable biliary tract cancer and to be suitable for combination chemotherapy on doctor’s discretion. Gemcitabine 1000 mg/m2 and oxaliplatin 60 mg/m2 were given every two weeks followed by capecitabine 1000 mg/m2 b.i.d. for one week. At one institution the oxaliplatin dose was 50 mg/m2 and capecitabine dose 650 mg/m2 b.i.d. continuously. One cycle included two treatments and was typically administered for up to six cycles/months, but was allowed for longer time until progression. Results: At institution A, 117 patients were included and 73 (62%) were women. Median age was 66 years (range 25-80). Median treatment duration was six cycles/months (range 1-12). Thirty-five, 69, 12, and one patient(s) were in performance status 0, 1, 2, and 3, respectively. Ninety patients were evaluable for response and 6 (7%) had complete response, 18 (20%) partial response, 53 (59%) stable disease, and 13 (14%) progression as best response. Median PFS was 9.7 months (95% CI 8.5-11.7) and median OS 11.7 months (9.8-14.0). The results were comparable to institution B, where the response rate in 56 patients with measurable disease was 30%. In 75 patients evaluable for survival analysis, PFS was 8.1 months and OS 12.0 months for performance status 0-1 (n=55). Patients in performance status 2 (n=25) had a PFS and OS of only 1.7 and 2.8 months, respectively. Conclusions: A triplet of gemcitabine, oxaliplatin, and capecitabine given in daily clinic was well tolerated and has effectiveness comparable to results from a phase II trial and the pivotal phase III trial of gemcitabine and cisplatin.

A phase II, open-label, randomized study to evaluate the efficacy and safety of GS-5745 combined with nivolumab versus nivolumab alone in subjects with unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4141-TPS4141 ◽  
Author(s):  
Manish A. Shah ◽  
Jean-Philippe Metges ◽  
Patrick Youngwhan Chun ◽  
Victoria Smith ◽  
Julia D. Maltzman ◽  
...  
Keyword(s):  
T Cell ◽  
Performance Status ◽  
Randomized Study ◽  
Gastroesophageal Junction ◽  
Cell Polarization ◽  
Phase Iii ◽  
Matrix Remodeling ◽  
Cell Trafficking ◽  
Efficacy And Safety ◽  
Open Label

TPS4141 Background: GS-5745 is a monoclonal antibody that inhibits matrix metalloproteinase 9 (MMP9), an extracellular enzyme involved in matrix remodeling, tumor growth, and metastasis. Inhibiting MMP9 is expected to block paracrine signaling and metastasis and to alter the immune microenvironment within the tumor. Results from the ATTRACTION-2 Phase III trial showed the PD-1 inhibitor nivolumab significantly improved overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) in patients with heavily pre-treated advanced gastric or gastroesophageal junction cancer. Preclinical studies indicate that selective inhibition of MMP9 can inhibit immune-suppressive myeloid cell polarization, regulatory T cell generation, desmoplasia, and the destruction of ligands for CXCR3 (a critical chemokine receptor that enables effector T cell trafficking). In combination with a checkpoint inhibitor, CD8+, CD4+ and CD44+ cytotoxic T cells are significantly increased in a checkpoint-refractory model, suggesting that MMP9 inhibition could relieve immune suppression. Methods: This phase 2, open-label, randomized study investigates the efficacy and safety of GS-5745 combined with nivolumab versus nivolumab alone in patients with unresectable or recurrent gastric or gastroesophageal adenocarcinoma. 120 patients will be randomized to either GS-5745 800mg IV + nivolumab 3mg/kg IV, or nivolumab alone. Treatment will be administered every 2 weeks and stratified by PD-L1 status. CT will be performed every 8 weeks to evaluate response. The primary endpoint of the study is ORR; secondary endpoints include PFS, OS, and occurrence of adverse events. Key inclusion criteria: metastatic or inoperable adenocarcinoma of the stomach or GEJ which has progressed after ≥1 prior systemic therapy, ECOG performance status ≤1, RECISTv1.1 measureable disease, archival tissue adequate for PD-L1 evaluation. Exploratory biomarkers correlated with study drug response will also be evaluated. Enrollment opened September 2016. Clinical trial information: NCT02864381.

Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive small-cell lung cancer: a phase III trial of the Southeastern Cancer Study Group.

1992 ◽  
Vol 10 (2) ◽  
pp. 282-291 ◽  
Author(s):  
B J Roth ◽  
D H Johnson ◽  
L H Einhorn ◽  
L P Schacter ◽  
N C Cherng ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Randomized Study ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Phase Iii Trial

PURPOSE The trial was undertaken to determine (1) the relative efficacy/toxicity of two commonly used combination chemotherapy regimens in patients with extensive small-cell lung cancer (SCLC) and (2) whether the rapid alternation of these two regimens could provide superior therapeutic results compared with either regimen alone. PATIENTS AND METHODS In this phase III trial, 437 eligible patients were stratified by performance status (PS) and sex and were randomly assigned to receive either 12 weeks of cisplatin and etoposide (EP); 18 weeks of cyclophosphamide, doxorubicin, and vincristine (CAV); or 18 weeks of alternation of these two regimens (CAV/EP). RESULTS There were no significant differences in treatment outcome for EP, CAV, or CAV/EP in terms of response rate (61%, 51%, 59%, respectively), complete response rate (10%, 7%, 7%, respectively), or median survival (8.6 months, 8.3 months, 8.1 months, respectively), with a non-statistically significant trend toward a longer median time to progression with alternating therapy (4.3 months, 4.0 months, 5.2 months, respectively). Crossover second-line chemotherapy given at progression produced low response rates and short survival, regardless of the regimen used. Myelosuppression was the dose-limiting toxicity for all patients, although the pattern and severity differed among the treatment arms. CONCLUSIONS The combination regimens EP and CAV can be considered equivalently effective induction therapies in extensive SCLC, and these two regimens are, to some degree, crossresistant. Alternating therapy provides no therapeutic advantage compared with the use of either of these regimens alone and should not be considered as standard treatment in this clinical setting.

Fludarabine and Cyclophosphamide Produces a Higher Complete Response Rate and More Durable Remissions than Fludarabine in Patients with Previously Untreated CLL: Intergroup Trial E2997.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 475-475 ◽  
Author(s):  
Ian W. Flinn ◽  
Elizabeth Kumm ◽  
Michael R. Grever ◽  
Donna Neuberg ◽  
Gordon W. Dewald ◽  
...  
Keyword(s):  
Performance Status ◽  
Randomized Study ◽  
Data Monitoring Committee ◽  
Progression Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
Data Monitoring ◽  
P Value ◽  
Fisher Exact Test ◽  
Monitoring Committee

Abstract The combination of fludarabine and cyclophosphamide (FC) has been noted to produce a high complete response rates in previously untreated patients with CLL. However, it may be accompanied by increased toxicity. To further evaluate its efficacy and toxicity, a phase III randomized study of FC versus Fludarabine (F) was conducted in patients with previously untreated CLL. The study, which was open to accrual from December 23, 1999 to March 19, 2004, closed with 278 patients enrolled, 141 on the FC arm and 137 on the F arm. Four patients declined to receive protocol treatment, including one who was later found to be ineligible. Five additional patients were also deemed ineligible. All patients with data are included in this analysis (intent to treat). Patients on the FC arm received C 600 mg/m2 iv day 1 and F 20 mg/m2 iv days 1 through 5, followed by filgrastim 5 mg/kg SC starting approximately day 8. Patients randomized to the F arm received F 25 mg/m2 iv days 1 through 5. In April 2004, the ECOG Data Monitoring Committee conducted a planned review at 76% information, and determined that the null hypothesis of no difference in CR rates could be rejected. The Data Monitoring Committee gave permission for the submission of abstracts to ASH. The median age of patients was 62 years (34–86), and the median performance status was 1 (0 to 2). As is expected in CLL, 70% of patients were male (194) and 30% were female (83). At study entry, 56% of cases were Rai stages, 0,1 or 2, while 44% were in stage 3 or 4. 57% of patients received the maximum of 6 cycles of therapy. Toxicity data is available on 127 CF and 125 F patients. There were two deaths due to infection with grade 3 or 4 neutropenia (one in each arm). In the CF arm, 17% of patients suffered grade 4 or higher non-hematologic toxicities, while in the F alone arm, 13% had higher grade toxicities (p= 0.48). Additionally, 17% of patients in the FC arm suffered infections versus 11% in the F alone arm (p= 0.21). Response data was available on 246 of the 278 patients. In the FC arm (125 cases), 28 patients achieved CR (22.4%), 60 patients achieved PR (48.0%) for a total of 88 objective responses (70.0%). In contrast, on the F alone arm (121 cases), there were 7 CRs (5.8%), 53 PRs (43.8%) for a total of 60 objective responses (49.6%). The Fisher exact test for the difference in CR rates gives a p-value of 0.0002, while the test for difference in OR rate was 0.001. Currently, 235 patients are alive and 42 have died. Among the 229 patients with information on time to progression, 131 are alive without progression, 78 have progression, and 20 have died without progression. 58 of the 78 with progressive disease remain alive. The preliminary estimates of the median progression free survival time are 41.0 months for the FC arm, and 17.7 months for the F alone arm ( p <0.001). It is noteworthy that the CR rate of F alone is similar to that reported by the GCLLSG (Eichhorst #243 ASH 2003). In summary, FC is a highly effective and tolerable regimen that produces more durable remissions than F in patients with previously untreated CLL.

Bevacizumab (BEV) plus chemotherapy (CT) continued beyond first progression in patients with metastatic colorectal cancer (mCRC) previously treated with BEV plus CT: Results of a randomized phase III intergroup study (TML study).

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. CRA3503-CRA3503 ◽  
Author(s):  
Dirk Arnold ◽  
Thierry Andre ◽  
Jaafar Bennouna ◽  
Javier Sastre ◽  
Pia J. Osterlund ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Response Rate ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Rank Test ◽  
Chi Square ◽  
Log Rank Test ◽  
Reported Data ◽  
The Impact

CRA3503 Background: BEV in combination with fluoropyrimidine-based CT is standard treatment for mCRC in the first-line (1L) and BEV-naïve second-line (2L) settings. This is the first randomized study evaluating the benefit of continuing BEV in combination with standard CT as 2L treatment for patients with mCRC who progressed after receiving a standard BEV-containing regimen in the 1L setting. Methods: Patients with unresectable, histologically confirmed mCRC who progressed within 3 months after discontinuation of 1L BEV + CT were randomised to 2L fluoropyrimidine-based CT ± BEV (2.5 mg/kg/wk equivalent). Choice of oxaliplatin- or irinotecan-based 2L CT was dependent on the regimen used in 1L (crossover) and included as a stratification variable. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), response rate and safety. Results: 820 patients were randomized from February 2006 to June 2010 (409 to BEV + CT and 411 to CT alone). Baseline patient and disease characteristics were well balanced between arms. The study met its primary endpoint; median OS was 11.2 months for BEV + CT and 9.8 months for CT (HR=0.81; 95% CI 0.69–0.94; unstratified log-rank test, p=0.0062). Median PFS was 5.7 months for BEV + CT and 4.1 months for CT (HR=0.68; 95% CI 0.59–0.78; unstratified log-rank test, p<0.0001). The response rate was 5.4% for BEV + CT and 3.9% for CT (unstratified Chi-Square Test, p=0.3113). The adverse event profile was consistent with previously reported data for BEV + CT. Compared with historical data from BEV treatment in 1L or 2L mCRC, BEV-related adverse events were not increased when continuing BEV beyond progression. Conclusions: This is the first randomized study to prospectively investigate the impact of continuing BEV treatment in 2L mCRC for patients who progressed after receiving a BEV-containing regimen in 1L. Our findings demonstrate that BEV + CT (crossed over from 1L regimen) continued beyond progression significantly prolongs OS and PFS in 2L mCRC. Additional analysis (including biomarker evaluation) is ongoing.

Final results of OV16, a phase III randomized study of sequential cisplatin-topotecan and carboplatin-paclitaxel (CP) versus CP in first-line chemotherapy for advanced epithelial ovarian cancer (EOC): A GCIG study of NCIC CTG, EORTC-GCG, and GEICO.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5502-5502 ◽  
Author(s):  
Andres Cervantes-Ruiperez ◽  
Paul Hoskins ◽  
Ignace Vergote ◽  
Elizabeth A. Eisenhauer ◽  
Prafull Ghatage ◽  
...  
Keyword(s):  
Residual Disease ◽  
Performance Status ◽  
Randomized Study ◽  
Objective Response ◽  
Progression Free Survival ◽  
Stage Ii ◽  
Phase Iii ◽  
Combination Regimen ◽  
Ecog Performance Status ◽  
Significant Difference

5502 Background: Topotecan was evaluated in a novel combination regimen in comparison to standard therapy in front-line EOC. Methods: Women with newly diagnosed advanced EOC stages IIB-IV, ECOG performance status (PS) 0-1, age < 75, were randomized to either Arm 1: cycles 1 - 4: cisplatin 50 mg/m2 d1 plus topotecan 0.75 mg/m2 d1-5 IV; cycles 5 - 8: paclitaxel 175 mg/m2over 3 hrs d1 followed by carboplatin AUC5 day 1 or Arm 2: paclitaxel plus carboplatin as in Arm 1 for 8 cycles. The primary endpoint was progression free survival (PFS) and secondary endpoints included objective response, overall survival (OS), adverse event (AE) and Quality of Life (QoL). The sample size required 800 pts and 631 events to detect an improvement in PFS from 16 to 20 months (power 80%, 2-sided alpha 0.05). Results with 3.6 years median follow-up (MFU) were reported previously: there was no significant difference in PFS (Hoskins P, JNCI 2010). Final results including OS after MFU of 8.2 years are reported. Results: From 2001 to 2005, 819 pts (409 Arm 1, 410 Arm 2) were randomized. 704 PFS events and 605 deaths have occurred. PFS results are similar to first report: Median (months [mo]): 14.6 (Arm 1) and 16.2 (Arm 2), hazard ratio (HR) 1.03 (95% CI:0.81-1.30; p = 0.83). Median OS is 44.2 mo (Arm 1) and 44.8 mo (Arm 2), HR: 0.92 (95% CI:0.71-1.19; p=0.54). Baseline factors found to be independent predictors of OS in multivariate analysis are: a) pre-randomization surgery (debulking with no macro residual disease (MRD) to no debulking HR: 0.47; 95%CI:0.37-0.58; p < 0.0001; debulking with MRD (<1 cm) to no debulking HR: 0.76; 95%CI:0.61-0.94; p = 0.01), b) Stage (stage II to III or IV HR:0.52; 95%CI:0.36-0.76; p = 0.0007) and c) PS (0 vs 1 HR:0.76; 95%CI:0.63-0.91; p = 0.004). Post-treatment AEs were not significantly different in the two arms. Conclusions: OV16 final results confirm that sequential doublets of topotecan and cisplatin followed by carboplatin and paclitaxel offer no improvement in outcomes compared to carboplatin and paclitaxel. Pretreatment debulking, stage II and PS 0 are predictive of longer OS. Clinical trial information: NCT00028743.

scholarly journals Protocol for a phase III randomized trial of chemoradiation and systemic chemotherapy vs. systemic chemotherapy alone in patients with unresectable nonmetastatic cholangiocarcinoma

2017 ◽  
Vol 4 (1) ◽  
pp. 14
Author(s):  
Supriya Chopra ◽  
Reena Engineer ◽  
Ashwathy Susan Mathew ◽  
Shaesta Mehta ◽  
Vikas Ostwal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Systemic Chemotherapy ◽  
Performance Status ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Phase Iii ◽  
Current Standard ◽  
The Impact ◽  
Doublet Chemotherapy

<p class="abstract"><strong>Background:</strong> Systemic doublet chemotherapy constitutes the current standard of care for patients with unresectable non-metastatic cholangiocarcinoma. The use of doublet chemotherapy is associated with median survival of 11.7 months. Concurrent chemo-radiation in this cohort is associated with similar overall survival however the impact of combination of chemoradiation and systemic chemotherapy on overall survival has not been investigated.  The present phase III randomized study investigates the impact of chemoradiation in addition to systemic chemotherapy on overall survival.</p><p class="abstract"><strong>Methods:</strong> Patients older than 18 years of age with diagnosis of unresectable non-metastatic cholangiocarcinoma with performance status 0-2and preserved liver function (Child Pugh score up to B7) will be eligible for study participation. The trial is designed such that patients will undergo stratified randomization (extra-hepatic vs. intrahepatic) either into systemic chemotherapy (standard arm) or chemo-radiation and systemic chemotherapy arm (experimental arm). The primary aim of the study is to compare difference in overall survival. The secondary aims of the study will focus on loco regional progression free survival and cause specific survival. The study will also report on the acute and late toxicity, quality of life and resectability rates in both the study arms. To demonstrate 7-month improvement in overall survival from 11 to 18 months a sample size of 142 is needed. Accounting for attrition a total of 155 patients will be accrued. All study subjects will be accrued after written informed consent. The trial is approved by the institutional ethics review board.</p><p>This trial is registered with ClinicalTrials.gov as NCT02773485</p>

scholarly journals Outcome of Allogeneic Transplantation for Mature T-cell Lymphomas: Impact of Donor Source and Disease Characteristics

2021 ◽  
Author(s):  
Mehdi Hamadani ◽  
Maud Ngoya ◽  
Anna Sureda ◽  
Qaiser Bashir ◽  
Carlos Alejandro Litovich ◽  
...  
Keyword(s):  
T Cell ◽  
Hematopoietic Cell Transplantation ◽  
Cell Lymphoma ◽  
Performance Status ◽  
Progression Free Survival ◽  
T Cell Lymphoma ◽  
Unrelated Donor ◽  
Marrow Graft ◽  
T Cell Lymphomas

Mature T-cell lymphomas constitute the most common indication of allogeneic hematopoietic cell transplantation (allo-HCT) in lymphomas. Large studies evaluating contemporary outcomes of allo-HCT in mature T-cell lymphomas, relative to commonly used donor sources are not available. Included in this registry study were adult patients who had undergone allo-HCT for anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma (AITL), or peripheral T-cell lymphoma-NOS (PTCL-NOS) between 2008 and 2018. HCT platforms compared were post-transplant cyclophosphamide-based haploidentical (haplo-) HCT, matched sibling donor (MSD) HCT, matched unrelated donor HCT with in-vivo T-cell depletion (MUD TCD+), and MUD HCT without TCD (MUD TCD-). Co-primary endpoints were overall survival (OS) and progression-free survival (PFS); secondary endpoints included non-relapse mortality (NRM), and relapse/progression incidence (RI). 1942 patients were eligible (haplo-HCT 237; MSD 911; MUD-TCD+ 468; MUD TCD- 326). Cohorts were comparable for baseline characteristics except higher proportions of patients with decreased performance status (PS) and marrow graft recipients in the haplo-HCT group. On univariate and multivariate comparisons, OS and PFS, RI, and NRM were not significantly different between haplo-HCT, MSD, MUD-TCD+, and MUD-TCD- cohorts, with 3-year OS and PFS of 60%, 63%, 59%, and 64%; and 50%, 50%, 48%, and 52%, respectively. Significant predictors of inferior OS and PFS on multivariate analysis were active disease status at HCT and decreased PS. AITL was associated with significantly reduced relapse risk and better PFS compared to PTCL-NOS. Allo-HCT can provide durable PFS in patients with mature T-cell lymphoma. Outcomes of haplo-HCT were comparable to that of matched donor allo-HCT.

A phase III randomized study comparing cisplatin and fluorouracil as single agents and in combination for advanced squamous cell carcinoma of the head and neck.

1992 ◽  
Vol 10 (2) ◽  
pp. 257-263 ◽  
Author(s):  
C Jacobs ◽  
G Lyman ◽  
E Velez-García ◽  
K S Sridhar ◽  
W Knight ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Randomized Study ◽  
Dose Intensity ◽  
Phase Iii ◽  
Hematologic Toxicity ◽  
Significant Difference

PURPOSE To determine whether combination chemotherapy is superior to single agents for recurrent/metastatic head and neck cancer, we compared the efficacy and toxicity of cisplatin (CP) and fluorouracil (5-FU), alone and in combination in a phase III trial. PATIENTS AND METHODS Two hundred forty-nine patients with recurrent head and neck cancer were randomized to one of three treatments: CP (100 mg/m2) and 5-FU (1 g/m2 x 4), CP, or 5-FU every 3 weeks. RESULTS The overall response rate to the combination (32%) was superior to that of CP (17%) or 5-FU (13%) (P = .035). Response was associated with good performance status (PS) but not with primary site, site of recurrence, histology, prior irradiation, or relative dose intensity. Median time to progression was less than 2.5 months, and there was no significant difference in median survival (5.7 months) among the groups. By multivariate analysis, patients with better PS and poorly differentiated tumors had superior survival. Hematologic toxicity and alopecia were worse in the combination arm. CONCLUSION Although the response rate to the combination of CP plus 5-FU was superior to that achieved with single agents, survival did not improve.

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