Phase II study of oxaliplatin-based chemotherapy in patients with advanced gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14119-14119
Author(s):  
E. Vattemi ◽  
R. Pedersini ◽  
B. Kildani ◽  
J. Stocker ◽  
S. Baier ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Disease Progression ◽  
Advanced Gastric Cancer ◽  
Progression Free Survival ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Median Number ◽  
Clinical Activity ◽  
Who Grade ◽  
Number Of Cycles

14119 Background: The aim of the study was to assess the toxicity and the clinical activity of oxaliplatin in combination with infusional 5-fluorouracil (5-FU) and folinic acid (FA) administered every 2 weeks in patients with advanced gastric cancer. Methods: 26 patients with recurrent and/or metastatic gastric cancer were enrolled. They received oxaliplatin 85 mg/mq on day 1, FA 200 mg/mq as a 2 h infusion followed by bolus 5-FU 400 mg/mq repeated for 2 consecutive days (FOLFOX-4). Treatment was repeated every two weeks until disease progression or limiting toxicity. Results: Patients had a median age of 62 years (range, 74–40); 19 patients had a PS of 0–1. Twenty patients had a newly diagnosed metastatic disease and 6 patients had recurrent disease. The median number of sites involved was 2. Four patients had prior adjuvant chemotherapy with cisplatin, 5-FU and epirubicin. So far, 22 of 26 patients are evaluable. The mean number of cycles was 8.6 (range, 2–15). One complete response (4.5%) and 9 partial responses (41%) were observed for an overall response rate of 45%. Stable disease was seen in 8 patients (36%) and disease progression occurred in 4 patients (18%) Median progression free survival was 4.7 months and median overall survival was 9.8 months. No WHO grade IV toxicity occurred and the only grade III toxicity was peripheral neuropaty (10%). The most commonly reported hematologic event was grade II neutropenia (20%) and trombocytopenia (15%). Conclusions: FOLFOX-4 regimen shows good efficacy and accetable safety profile in advanced gastric patients. No significant financial relationships to disclose.

Retrospective review of modified dose docetaxel, cisplatin, and 5-flourouracil (DCF) for the treatment of first-line metastatic gastric carcinomas.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15175-e15175
Author(s):  
Nuriye Özdemir ◽  
Sercan Aksoy ◽  
Tulay Eren ◽  
Huseyin Abali ◽  
Omur Berna Oksuzoglu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Retrospective Review ◽  
Progression Free Survival ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Median Number ◽  
Hematological Toxicity ◽  
First Line ◽  
Gastric Carcinomas ◽  
Grade 3

e15175 Background: Docetaxel, cisplatin, and 5FU (DCF) has been shown to be an effective regimen for metastatic gastric carcinomas. However, treatment-related adverse events is quite high with original dose DCF. We evaluated the outcomes of the metastatic gastric carcinomas who treated with modified dose DCF (mDCF) in our institution. Methods: A single institution retrospective review of patients with metastatic gastric cancer treated with three weekly mDCF from 1/2006 to 1/2013 was evaluated. Over this time period a standard order-set was in place in which cisplatin 60 mg/m2, 5FU 600 mg/m2 and docetaxel 60 mg/m2 was given three weekly. Tumor response was calculated retrospectively using RECIST criteria. Results: One hundred and ninety-one patients were included the study. The median age was 55 years (23 to 76), 74% were male, and 82% were chemo-naive. Eighty percent of the patients were metastatic at the time of diagnosis. The median number of cycles administered was 6 (2-10). Hematological toxicity was mild with grade 3/4 granulocytopenia in 25% of the patients, grade 3/4 thrombocytopenia in 4% of the patients, and grade 3/4 anemia in 9% of the patients. Neutropenic infection occurred in 9 (%5) patients. Grade 3/4 nausea/vomiting was reported by 10% of the patients, and diarrhea by 7%. A total of 19 (10%) patients had dose delays or dose reductions related to toxicity. Six (3%) patients had complete response and 43 (23%) patients had partial response. Stable disease were occurred in 83 (45%) patients and 56 (23%) progressive disease. Ninety percent of the patients have died with median follow-up of 8 months. Progression-free survival was 7 months (95% CI 6 to 7.8 m) and overall survival was 10 months (95% CI 8.7 to 11.2 m). Conclusions: mDCF has mild hematological toxicity and overall excellent tolerance in first line metastatic gastric cancer patients. Response rate and the survival of these patients with a minimal toxicity are comparable with the original dose DCF.

Oxaliplatin, 5-fluorouracil, and folinic acid as first-line chemotherapy for elderly patients with advanced gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14155-14155 ◽  
Author(s):  
I. Choi ◽  
K. Lee ◽  
D. Oh ◽  
J. Kim ◽  
S. Lee ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Elderly Patients ◽  
Folinic Acid ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
First Line ◽  
Line Chemotherapy

14155 Background: We investigated the efficacy and safety of an oxaliplatin, 5-fluorouracil (5-FU), and folinic acid (FA) as first-line chemotherapy for elderly patients with advanced gastric cancer. Methods: Chemotherapy-naïve patients (≥65 yr of age) with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Chemotherapy consisted of oxaliplatin 100 mg/m2 and FA 100 mg/m2 (2-hour intravenous infusion), then 5-FU 2400 mg/m2 (46-hour continuous infusion) every 14 days. Results: A total of 24 patients were enrolled between September 2003 and July 2005. Of 22 evaluable patients, none achieved complete response (CR) and 11 achieved partial response (PR), resulting in an overall response rate of 50%. Median progression-free survival (PFS) was 5.4 months (95% CI: 5.1–5.8 months) and median overall survival (OS) was 7.4 months (95% CI: 4.4–10.4 months). The main toxicities were anemia and leucopenia, which were observed in 39.8% and 19.0%, respectively, of the total cycles administered. There were 2 cycles of grade 4 leucopenia and febrile neutropenia was not observed. Conclusions: This oxaliplatin/5-FU/FA regimen shows good efficacy and an acceptable toxicity profile in elderly patients with advanced gastric cancer. No significant financial relationships to disclose.

Phase II Activity of Belinostat (PXD-101), Carboplatin, and Paclitaxel in Women With Previously Treated Ovarian Cancer

2012 ◽  
Vol 22 (6) ◽  
pp. 979-986 ◽  
Author(s):  
Don S. Dizon ◽  
Lars Damstrup ◽  
Neil J. Finkler ◽  
Ulrik Lassen ◽  
Paul Celano ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Confidence Interval ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Clinical Activity ◽  
Phase 2 ◽  
Resistant Disease ◽  
Novel Approach

BackgroundPreclinical data show that belinostat (Bel) is synergistic with carboplatin and paclitaxel in ovarian cancer. To further evaluate the clinical activity of belinostat, carboplatin, and paclitaxel (BelCaP), a phase 1b/2 study was performed, with an exploratory phase 2 expansion planned specifically for women with recurrent epithelial ovarian cancer (EOC).MethodsThirty-five women were treated on the phase 2 expansion cohort. BelCap was given as follows: belinostat, 1000 mg/m2 daily for 5 days with carboplatin, AUC 5; and paclitaxel, 175 mg/m2 given on day 3 of a 21-day cycle. The primary end point was overall response rate (ORR), using a Simon 2 stage design.ResultsThe median age was 60 years (range, 39–80 years), and patients had received a median of 3 prior regimens (range, 1–4). Fifty-four percent had received more than two prior platinum-based combinations, sixteen patients (46%) had primary platinum-resistant disease, whereas 19 patients (54%) recurred within 6 months of their most recent platinum treatment. The median number of cycles of BelCaP administered was 6 (range, 1–23). Three patients had a complete response, and 12 had a partial response, for an ORR of 43% (95% confidence interval, 26%–61%). When stratified by primary platinum status, the ORR was 44% among resistant patients and 63% among sensitive patients. The most common drug-related adverse events related to BelCaP were nausea (83%), fatigue (74%), vomiting (63%), alopecia (57%), and diarrhea (37%). With a median follow-up of 4 months (range, 0–23.3 months), 6-month progression-free survival is 48% (95% confidence interval, 31%–66%). Median overall survival was not reached during study follow-up.ConclusionsBelinostat, carboplatin, and paclitaxel combined was reasonably well tolerated and demonstrated clinical benefit in heavily-pretreated patients with EOC. The addition of belinostat to this platinum-based regimen represents a novel approach to EOC therapy and warrants further exploration.

Neoadjuvant chemotherapy for locally advanced cervical cancer: Experience at the Instituto Oncologico Nacional SOLCA Guayaquil.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15571-e15571
Author(s):  
Guillermo Paulson ◽  
Katherine Garcia ◽  
Mayra Santacruz ◽  
Ruth Ginger Engracia ◽  
Jose Francisco Mendoza
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Invasive Cervical Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Number Of Cycles ◽  
Clinical Records ◽  
Cancer Experience

e15571 Background: Cervical cancer is the most common malignancy of women in Ecuador. The main problem of concomitant chemo-radiotherapy (CRT) is the delay in starting radiation therapy, economic and logistical problems for high demand in radiotherapy. It has been neoadjuvant chemotherapy (NACT) followed by CRT the main treatment at our center in order to find an alternative to long waits before the start of radiotherapy. The aim of this study was to determine the response to NACT followed by CRT in terms progression-free survival (PFS) and overall survival (OS). Methods: diagnosed with invasive cervical cancer locally advanced stage II-III were analyzed retrospectively reviewed clinical records of pre-existing data from 2008 to 2010. Results: after meeting the criteria of exclusion, leaving 116 cases. The median age: 49 years (range: 28-82 years). The histology was 73% (85) squamous cell carcinoma, 26% (30) adenocarcinoma and 0.9% (1) not specified. Patients with stage IIB: 81.9% (95), IIIA: 10.3% (12), IIIB: 7.8% (9). Of the 116 patients 69% (80) received NACT. The main NACT was paclitaxel 175mg/m2 + Cisplatin 75mg/m2 every 3 weeks 63.8% (74), the remaining group received another protocol, the median number of cycles of NACT was 5 (1 - 8 cycles), the start of radiotherapy since the conclusion of NACT was 53 days on average (1 to 285 days) and the main regimen of CRT concomitant was cisplatin 40mg/m2 weekly 47.5% (38). In the 49 patients who underwent NACT followed by CRT, a radiological study showed, complete response (CR) 38.8% (19), 18.4% partial response (PR) (9), disease progression (DP) 12.2% (6), stable disease (SD) 8.2% (4) and the end of treatment evaluation gynecological was performed and CR was obtained in 59.2% (29). Persistent or progressive disease after treatment was 22.4% (11), recurrence was 12.2% (6), local recurrence 2.0% (1), distant metastasis 10.2% (5). OS of NACT followed by CRT was 93.9% (46) and PFS was 65.3% (32), OS after CR was 96% (25 / 1) and then 91.7% PR (24 / 2) with p: 0.439. Conclusions: NACT followed by CRT is a valid option because it improves disease-related symptoms, but OS did not improve significantly even after CR.

Comparison of efficacy of aspirin plus epirubicin, oxaliplatin, and capecitabine versus epirubicin, oxaliplatin, and capecitabine alone in patients with locally advanced and metastatic gastric cancer: A randomized clinical trial.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 384-384
Author(s):  
Esha Jafa ◽  
Biswajit Dubashi ◽  
Smita Kayal ◽  
Vikram Kate ◽  
Rajesh Nachiappa Ganesh ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Protocol Analysis ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Response Rates ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Response To Treatment ◽  
Significant Difference

384 Background: Aspirin was long known to prevent cancer, the last decade revealed its therapeutic role via varied mechanisms like inhibition of platelet activation, COX and PI3K pathway. Since PI3K/AKT/mTOR is one of the pathways activated in gastric cancer and Giampieri et al (2016) showed improved response rates, PFS and OS with addition of aspirin to capecitabine in heavily pretreated metastatic colorectal cancer,a cancer in which efficacy of aspirin is related to presence of PI3K mutations,we aimed to compare the efficacy of aspirin added to a standard regime EOX with EOX alone in locally advanced and metastatic gastric cancer. Methods: All patients with advanced gastric cancer coming to JIPMER,Department of Medical oncology between march 2017 to may 2019 were screened for eligibility in the trial.Those eligible were randomly assigned to standard EOX or standard EOX plus 150 mg of daily aspirin.Tumor measurements were performed at baseline,then after 3-4 cycles (interim response) and the response to treatment was assessed by the radiologist who was blinded to treatment arms according to RECIST1.1 criteria.Toxicity profiles were recorded as per CTCAE v 4.03.In per protocol analysis,response rates, PFS(progression free survival) and OS (overall analysis) were analysed for patients who received ≥3 cycles and had an evaluable interim response. Results: 95 patients were randomised.In per protocol analysis, 70 patients were included. The results are shown in table. Conclusions: No statistically significant difference was seen with respect to response rates, PFS, OS and toxicity, although there was a higher ORR (overall response rate=complete response,CR +partial response, PR) and OS seen in EOX plus aspirin arm. Clinical trial information: CTRI/2017/11/010651. JIPMER,Puducherry,India [Table: see text]

Treatment outcome and safety of docetaxel as the third-line chemotherapy in advanced gastric cancer after progression or after failure of FOLFOX and FOLFIRI-based sequential chemotherapy.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 133-133
Author(s):  
I. Hwang ◽  
J. Kang ◽  
B. Park ◽  
S. Park ◽  
M. Jang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Disease Progression ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Progression Free Survival ◽  
Salvage Chemotherapy ◽  
The Third ◽  
Third Line ◽  
Grade 3 ◽  
Line Chemotherapy

133 Background: We performed multicenter retrospective study to evaluate the activity and the safety of a docetaxel as the third-line chemotherapy in advanced gastric cancer (AGC) patients who had undergone oxaliplatin (FOLFOX) and irinotecan (FOLFIRI)-based chemotherapy regimens. Methods: Thirty-eight patients with AGC previously treated were eligible for this study. Patients received docetaxel 30 mg/m2 +/- cisplatin 30 mg/m2 IV on day 1, 8 or docetaxel 60 mg/m2 +/- cisplatin 60 mg/m2 IV on day 1 every 3 weeks until disease progression, and responses were assessed after every two cycles according to RECIST criteria and toxicity was evaluated by NCI-CTC. Results: Thirty-two out of 38 patients were evaluable for response. A total of 95.1 cycles of chemotherapy (median 2, range 0.5–7) were administered. Relative dose intensities of docetaxel and cisplatin were 93.4% and 87.8%, respectively. The overall response rate was 15.6% and the disease control rate was 50%. With a median follow-up duration of 3.1 months (range 0.3-14.3 months), 36 patients had disease progression, and 34 patients had died at the time of analysis. The median progression-free survival was 1.8 months (95% CI, 1.3–2.3 months). The median overall survival was 3.1 months (95% CI, 2.3–3.9 months). Grade 3 or 4 hematologic toxicities included neutropenia in thirteen patients (38.3%), febrile neutropenia in four patients (11.7%). and thrombocytopenia in one patient (2.9%). Other grade 3 or 4 toxicities included neuropathy in three patients (8.8%) and mucositis in two patients (5.9%). There were three treatment-related deaths (8.8%) caused by infection associated with neutropenia. Conclusions: Salvage docetaxel chemotherapy in AGC patients failed in oxaliplatin and irinotecan-based treatment is not recommend routinely. However, selected patients with good performance status and sufficient albumin levels may have derived some survival benefits from salvage chemotherapy. No significant financial relationships to disclose.

ECX as neoadjvuant chemotherapy for gastric cancer in South America.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15190-e15190
Author(s):  
Leandro Machado Colli ◽  
Antonio Carlos Godoy ◽  
Bruno Filardi ◽  
Jose Marcio Barros Figueiredo ◽  
José Sebastião Santos ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Disease Progression ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Progression Free Survival ◽  
Complete Response ◽  
Brazilian Population ◽  
South American ◽  
South American Population

e15190 Background: Gastric cancer is a common malignant disease with a high mortality rate. Neoadjuvant treatment is efficient, but not the first option for treatment in all countries. Studies of neadjuvant chemotherapy in gastric cancer in South American countries are lacking. The aim of this retrospective analysis was to investigate the use of the ECX (epirubicin, cisplatin, and capecitabine) regimen in the neoadjuvant therapy in a Brazilian population. Methods: 25 patients (median age, 61; range 36-78 years; 14 pts >60 years) with locally advanced gastric adenocarcinoma received three courses of preoperative chemotherapy with epirubicin 50 mg/m², day 1, cisplatin 60 mg/m², day 1, and capecitabine 625 mg/m² bid, days 2-21, of a 21-day cycle. Toxicity was assessed by the Common Toxicity Criteria (CTC) after every cycle. Progression-free survival (PFS) was defined as time from diagnosis to disease progression assessed by CT. Results: 21 pts completed all three planned cycles of neoadjuvant chemotherapy. Four patients receiced surgery earlier than planned due to bleeding (1), toxicity (1), abdominal infection (1), and non-adherence to treatment (1). Three patients could not be operated due to disease progression. 70% of operated patients had curative resection with two pathologic complete response. Only six out 25 patients had disease progression and only two died after a median follow-up of 11.5 months (range 3.4-20.2). Median PFS and overall survival were not reached. Toxicities grade 3-4 were neutropenia (28%), febrile neutropenia (8%), bleeding (8%), and heart failure (6,2%). Conclusions: ECX is a efficacious neoadjuvant treatment in the Brazilian population and also well tolerated and safe. However, more studies with a larger South American population are needed.

The combination of the changes and the value of neutrophil-to-lymphocyte ratio is useful for prediction of response for advanced gastric cancer treated with nivolumab: A multicenter retrospective study.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 150-150
Author(s):  
Takatsugu Ogata ◽  
Hironaga Satake ◽  
Misato Ogata ◽  
Kentaro Inoue ◽  
Madoka Hamada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Progression Free Survival ◽  
Complete Response ◽  
Class Ii ◽  
Neutrophil To Lymphocyte Ratio ◽  
Class I ◽  
Class Iii ◽  
Lymphocyte Ratio ◽  
Ecog Ps

150 Background: The ATTRACTION-2 study showed that nivolumab is effective in treating advanced gastric cancer (AGC). Many studies have examined the effectiveness of predictive factors. We previously suggested that neutrophil-to-lymphocyte ratio (NLR) was associated with progression-free survival (PFS) and overall survival. The objective of this study was to determine the effectiveness of the changes of NLR for AGC treated with nivolumab. Methods: Data on patients with AGC treated with nivolumab from November 2014 to December 2017 were collected at two centers. NLRs were calculated before the first cycle (NLRpre) and 2 weeks after the first cycle (NLRpost) of nivolumab, and the changes in NLR (cNLR) was calculated by NLRpost/NLRpre. The association of NLRpre and cNLR with the disease control rate (DCR) and PFS were assessed. Results: Forty-one patients (pts), with the median age of 64 years, were enrolled. Twenty-seven pts were men and 14 were women. Regarding ECOG PS, 34 pts had scores of 0-1 and 7 had a score of 2. The median NLRpre, NLRpost, and cNLR were 2.01 (range, 0.79–18.4), 2.76 (1.27–12.3), and 1.22 (0.16–5.20), respectively. With a median follow-up period of 6.1 months, DCR was 34.1% (complete response [CR], 1 pt; partial response [PR] 3 pts, stable disease [SD], 10 pts). Patients were divided into 3 classes: 8 in Class I (NLRpre≤5 and cNLR≤ 1); 17 in Class II (NLRpre ≤ 5 and 1 < cNLR≤ 2); and 16 in Class III (NLRpre> 5 or cNLR > 2). There were 8 pts, 17 pts, and 16 pts in Class I, II, and III, respectively. DCRs of Class I, II, and III was 87.5% (CR, 1 pt; PR, 2 pts; SD 4 pts), 29.4% (PR, 1 pts; SD 4 pts), and 12.5% (SD 2 pts), respectively. The median PFS was 2.0 months (mo), and it was longer in Class I than in Classes II+III (5.6 vs. 1.4 mo; p = 0.017) and shorter in Class III than in Classes I+II (3.1 vs. 1.3 mo; p = 0.008). The median PFS was 2.0 months (mo). The median PFS was longer in Class I compared with in Class II+III (5.6 vs 1.4 mo; p = 0.017). The median PFS was shorter in Class III compared with in Class I+II (3.1 vs 1.3 mo; p = 0.008). Conclusions: The combined use of NLRpre and cNLR seemed to be effective in predicting the response of AGC to nivolumab.

Negative association between antibiotics and clinical activity in patients with advanced gastric cancer

2020 ◽  
Author(s):  
Xiaoyun Zhang ◽  
Hui Jin ◽  
Boya Jing ◽  
Ruixue Lai ◽  
Yufei Zhao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Gut Microbiota ◽  
Advanced Gastric Cancer ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Treated Group ◽  
Control Group ◽  
Clinical Activity ◽  
Primary Resistance ◽  
Chemotherapy Efficacy

Abstract Background Antibiotics (ATBs) induce dysbiosis of the gut microbiota by altering the diversity and composition of the microbiota, which mediates the efficacy and toxicity of cancer therapy. The influence of dysbiosis induced by ATB administration on primary resistance to chemotherapy in patients with advanced gastric cancer (GC) has rarely studied. We evaluated the effect of ATB administration on chemotherapy efficacy in patients with advanced GC. Methods Patients with GC were divided into two groups according to the statues of ATB administration: ATB-treated and control groups. Tumor responses, progression-free survival (PFS), and overall survival (OS) were assessed. Results We found that the incidence of progressive disease in the ATB-treated group was significantly higher when compared with that in the control group that received no ATB treatment (72.73% vs. 29.55%, p = 0.007). In addition, ATB administration was associated with shorter PFS [median PFS: 1.47 vs. 4.97 months, hazard ratio (HR): 2.296, 95% confidence interval (CI): 1.214–4.342, p = 0.011] and reduced OS (median OS: 9.97 vs. 13.3 months, HR: 2.101, 95% CI: 1.030–4.286, p = 0.041) based on univariate analysis. Subsequent multivariate analysis also indicated that ATB administration was an independent prognostic factor for PFS (HR: 3.361, 95% CI: 1.592–7.097, p = 0.001) and OS (HR: 2.280, 95% CI: 1.042–4.991, p = 0.039). Conclusions ATB administration is associated with reduced chemotherapy efficacy and poor prognosis in patients with advanced GC. Modulations in ATB-related dysbiosis and gut microbiota composition improve the clinical outcomes of chemotherapy.

Bendamustine Treatment in Refractory or Relapsed T Cell Lymphomas: A Retrospective Multicenter Study

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1505-1505
Author(s):  
Emilie Reboursiere ◽  
Fabien Le Bras ◽  
Franck Morschhauser ◽  
Emmanuel Gyan ◽  
Aline Clavert ◽  
...  
Keyword(s):  
T Cell ◽  
Disease Progression ◽  
Single Molecule ◽  
Therapeutic Option ◽  
Single Agent ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Biological Data ◽  
Advisory Boards

Abstract Peripheral T-cell lymphoma (PTCL) is an aggressive disease with poor outcome. First line therapies are usually unsatisfactory with frequent need for second-line therapies. Median progression free survival (PFS) and overall survival (OS) for relapse PTCL patients are very short with few available therapeutic options. Bendamustine has been shown to be effective in this setting. In order to assess the efficacy of bendamustine outside clinical trials, we conducted a national retrospective study of patients with the diagnosis of PTCL and who were treated with bendamustine. Between 2011 and 2013, about 200 patients with the diagnosis of PTCL have been treated in 27 centers with bendamustine. We present the results of 142 patients with complete clinical and biological data. The population median age was 64y (range 28-89) with male/female sex ratio of 1,4 (83/59). Histologies were: angio-immunoblastic (AILT=63), PTCL-NOS (n=44), anaplasic-large (ALCL=13), NK/TCL (n=3), mycosis fungoides (MF=7), subcutaneous panniculitis-like-TCL (n=2), hepato-splenic-TCL (n=1) and others (n=9). The majority of patients (96%, n=130) had stage-disseminated disease and 72% (n=102) of them had extranodal localisations. The median number of chemotherapy lines prior to bendamustine was 2 (range 0-8). Seven patients (5%) had received allogeneic stem cells transplantation (SCT) and 16 autologous SCT (11%) prior to bendamustine. The median duration of response (DoR) after the last prior to bendamustine chemotherapy was 4.3 months (range 1-70) and 50% of patients had refractory disease at bendamustine treatment. Seventy-four patients (52%) received less than 3 cycles, mostly because of disease progression. Overall, they received a median of 2 cycles (range 1-8) with a median dose of 90mg/m2 (range 50-150). The best overall response rate (ORR) was 32% (45/141) with complete response of 24% (CR=34). The median DoR was 3.3 months (1-39). For AITL patients, ORR was 52% (33/63) with CR of 41%, whereas it was 18% (8/44) with 11% of CR, in patients with PTCL-nos, respectively (p=0.01). Nine patients (6%) received allogeneic SCT in CR. Median PFS was 3 months (range 0.2-46.3) and median OS was 4.4 months (range 0.2-55.4). On multivariate analysis, chemotherapy refractory (p=0.001) patients' and extranodal disease localization (p=0.028) before bendamustine influenced adversely the ORR. With a median follow up 4.4 months, 72% of patients (102/142) died. The most frequent cause of death were: disease progression (92%) or toxicities (6%). Grade 3-4 thrombocytopenia, neutropenia and infections were reported in 22%, 17% and 23% of cases, respectively. Bendamustine as single agent must be considered as a therapeutic option for relapsed or refractory PTCL, particularly in patients with AITL. The safety profile was good. Combination of bendamustine with other drugs should be evaluated prospectively. Disclosures Off Label Use: Bendamustine, single molecule, alkylant agent with antimetabolite properties. Morschhauser:Genentech Inc./Roche: Other: Advisory boards. Cartron:Sanofi: Honoraria; GSK: Honoraria; Celgene: Honoraria; Gilead: Honoraria; Roche: Consultancy, Honoraria.

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