The Ribvd Regimen (Rituximab IV, Bendamustine IV, Velcade SC, Dexamethasone IV) Offers a High Complete Response Rate In Elderly Patients With Untreated Mantle Cell Lymphoma. Preliminary Results Of The Lysa Trial “Lymphome Du Manteau 2010 SA”

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 370-370 ◽  
Author(s):  
Remy Gressin ◽  
Mary Callanan ◽  
Nicolas Daguindau ◽  
Adrian Tempescul ◽  
Sylvain Carras ◽  
...  
Keyword(s):  
Response Rate ◽  
Complete Response ◽  
Primary Prophylaxis ◽  
High Response Rate ◽  
Hematological Toxicity ◽  
Molecular Response ◽  
Virus Reactivation ◽  
Serious Adverse Events ◽  
Cutaneous Rash ◽  
The Impact

Abstract This prospective phase II trial (Nov 2011- Dec 2012), supported by the LYSA group, aimed to evaluate the impact on PFS of the RiBVD regimen in newly diagnosed, previously untreated, elderly MCL patients (>65 years or not eligible for ASCT) (NCT01457144). Inclusion criteria were: WHO 2008 MCL not previously treated, CD20 positive, ECOG 0-2, AA stage II-IV, no CNS involvement or active HBV/HCV/HIV infection. Patients were scheduled to receive a total of 6 cycles of the RiBVD regimen, if they responded (IWG criteria) after 4 cycles. The regimen was administered every 4 weeks with Rituximab 375 mg/m² IV on day(D)1, Bendamustine 90 mg/m² IV on D1 and 2, Dexamethasone 40 mg/m² IV on D2 and bortezomib (Velcade®) 1.3 mg/m² subcutaneously on D1, 4, 8 and 11. Primary prophylaxis with acyclovir was mandatory for Herpes virus reactivation, but there was no recommendation for bacterial prevention. Herein we present preliminary analysis of the trial after 4 RiBVD cycles. Results: A total of 76 patients were included, one was excluded because of HBV active disease and 5 had insufficient data reported in the database. To date we analyzed 70 patients. Patients characteristics: sex ratio M/F 49/21, median age 72 years (y) [64-83] (2 patients were 64 y old), AAstage II/III-IV 5/65, ECOG 0-1/2 59/11, MIPI score low/intermediate/high 3/19/48. Response: 61 responded (ORR=87%), with 19 in PR (26%) and 42 in CR/CRu (60%). Four patients died from pneumonia (n=1), cardiac arrest (n=2) and one following Progressive Multifocal Leukoencephalopathy. Three patients have progressed after 3 cycles. Sixty one patients were analysed by PETscan after 4 cycles, 39 (64%) reached a CR (30 were in CR/CRu and 9 in PR) and 22 remained PET positive (11 patients were in CR/CRu, 10 in PR and 1 stable). RiBVD cycles: 271 cycles were administered out of 280 planned (97%). Twenty four (9%) were delayed, 10 for toxicity. All but one planned Bendamustine doses (n=542) were administered with dosing modified 17 times (3%), mostly for hematological toxicity (n=14). Regarding Bortezomib, 79% (1028/1084) of planned doses were administered, it was prematurely stopped (56, 4%) for neurotoxicity (10 instances) or hematological side effects (46). Rituximab was not administered in 4 instances. Hematologic toxicities: Over the 271 cycles administered, neutropenia was reported in 104 cycles [56 grade 3/4 (g3/4) (21%)], 2.5% with fever; thrombopenia in 181 cycles [41 g3/4 (15%)]; anemia in 210 cycles, [6 g3/4 (2%)]. Non-hematologic toxicities:Reported in >10% of the cycles were : allergic reactions (10.3%, g3/4 <1%), fatigue (40%, g3/4 5%), fever without neutropenia (12%, g3/4 none), weight loss (12%, g3/4 0%), cutaneous rash (12%, g3/4 1.5%), gastrointestinal (40%, g3/4 1.5% ; diarrhea 8%, constipation 17% or emesis 15%), elevated transaminases (14%, g3/4 1%), creatinin (13%, g3/4 none), or glucose (18%, g3/4 1%) ; neuropathy (sensitive or pain) (25%, g3/4 4%). Serious adverse events (SAE) additional to the 4 deaths, were 12 infections including 3 pneumonias (no pneumocystosis), one listeriosis and 2 herpes zoster. Four febrile neutropenia and 3 cutaneous hypersensitivity episodes were also reported. Conclusion Despite 4 toxic deaths (6%), toxicity appears acceptable and manageable. In particular, subcutaneous bortezomib shows markedly decreased neurotoxicity compared to the IV form. This interim analysis shows that four cycles of RiBVD are very effective for untreated elderly MCL patients (ORR 87%) with a high response rate (CR/CRu 60%) which has been shown to be predictive of a long duration of response. An update of these results will be presented at the ASH meeting together with the molecular response rates after 4 cycles. Disclosures: Gressin: Pfizer: Consultancy; Mundipharma: Consultancy. Cartron:Roche: Membership on an entity’s Board of Directors or advisory committees.

Lenalidomide/Dexamethasone Improves Response and Prolongs Time to Progression, Even in Patients with IgA Multiple Myeloma: A Sub-Analysis of the MM-009/010 Studies.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4839-4839 ◽  
Author(s):  
Robert Foa ◽  
Donna Weber ◽  
Meletios Dimopoulos ◽  
Marta Olesnyckyj ◽  
Zhinuan Yu ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Response Rate ◽  
Complete Response ◽  
High Response Rate ◽  
Response To Therapy ◽  
Phase Iii ◽  
Time To Progression ◽  
Phase Iii Trials ◽  
The Impact

Abstract Background: Historically, patients with IgA multiple myeloma (MM) respond poorly to treatment. In 2 recent phase III trials, Lenalidomide (Len) in combination with Dexamethasone (Dex) led to an overall response (OR) rate of approximately 60% (61% in MM-009 and 60% in MM-010), a complete response (CR) rate of about 15% (14% and 16%, respectively), an overall survival (OS) of at least 29.5 months (29.5 and not yet reached), and a median time to progression (TTP) of at least 11.1 months (11.1 months and 11.3 months, respectively) in patients with relapsed/refractory MM. In both studies, OR, CR, OS and TTP were significantly better with Len/Dex than with Dex alone. Here, we assess the impact of IgA disease on the efficacy and tolerability of treatment with Len/Dex versus Dex alone. Methods: Data were pooled from the MM-009 and MM-010 studies. Patients were randomized to receive Len (25 mg/day on days 1–21 of each 28-day cycle) or placebo. Both groups received Dex 40mg PO q.d. on days 1–4, 9–12, and 17–20 (for the first four cycles). After four cycles, Dex 40 mg/day was administered only on days 1–4. Response to therapy, TTP, OS, and adverse events were assessed. Response rate and TTP were based on data obtained before unblinding (June 2005 [MM-009] and August 2005 [MM-010]). Results: Of 154 patients with IgA at baseline, 72 were treated with Len/Dex and 82 with Dex alone. Among those without IgA, 281 received Len/Dex and 269 received Dex alone. Baseline characteristics were balanced between treatment groups. Len/Dex was associated with a significantly higher OR and longer median TTP than Dex alone in patients with and without IgA (Table). In the non-IgA group, patients treated with Len/Dex had a significantly longer OS than those treated with Dex alone. Response, TTP and OS were comparable between IgA and non-IgA patient groups. There was no difference in the incidence of adverse events between patients with and without IgA. Among those with IgA, the most common grade 3–4 adverse events with Len/Dex and Dex alone were neutropenia (37.5% and 2.4%), thrombocytopenia (16.7% and 8.5%), and anemia (11.1% and 7.3%). The respective rates for patients without IgA were 46.5% and 14.5%, 12.1% and 5.7%, and 11.0% and 5.7%. Conclusion: In patients with and in those without IgA MM, Len/Dex treatment induces a high response rate and a prolonged TTP compared with Dex. IgA non-IgA Clinical response, % Len/Dex (n=72) Dex alone (n=82) P Len/Dex (n=281) Dex alone (n=269) P OR 68.1 18.3 <0.001 57.7 23.0 <0.001 CR 18.1 0 NS 14.2 2.6 NS PR 38.9 15.9 NS 35.6 19.3 NS Median TTP, wks 44.3 16.4 <0.001 52.1 20.1 <0.001 Median OS, wks 130.4 102.4 NS 156.0 136.1 <0.05

scholarly journals Waning Humoral Response 3 to 6 Months after Vaccination with the SARS-COV-2 BNT162b2 mRNA Vaccine in Dialysis Patients

2021 ◽  
Vol 11 (1) ◽  
pp. 64
Author(s):  
Noa Berar-Yanay ◽  
Sarit Freiman ◽  
Maʹanit Shapira ◽  
Amer Saffoury ◽  
Ameer Elemy ◽  
...  
Keyword(s):  
Response Rate ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Albumin Level ◽  
High Response Rate ◽  
Control Group ◽  
Dialysis Patients ◽  
Serious Adverse Events ◽  
Antibody Levels

Background and objectives: The short-term reported antibody response to SARS-COV-2 vaccination in dialysis patients is high, with a seroconversion response rate up to 97%. Data on the long-term durability of this response are scarce. Our objective was to characterize the long-term anti-spike antibody level in dialysis patients. Design, setting, participants, and measurements: In an observational study, we measured SARS-COV-2 anti-spike antibody levels in dialysis patients who completed 2 doses of the BNT162b2 mRNA SAR S-COV-2 vaccine at 1, 3 and 6 months after the second vaccine dose. We compared the response to dialysis patients who were infected with COVD-19 and to a control group of healthcare-employees. Results: One hundred and forty-two dialysis patients who had been vaccinated (ages 64 ± 11.9 years, 61% male), 33 dialysis patients who had COVID-19 infection (ages 54 ± 14.3 years, 55% male) and 104 individuals in the control group (ages 50 ± 12.2 years, 44% male) were included. The response rate in the vaccinated dialysis patients was 94%, 78% and 73% at 1, 3 and 6 months after the second vaccine dose. In the COVID-19 infected dialysis group and in the control group, the response rate remained at 100% over 6 months. The percentage of change in antibody levels between one and 6 months was −66% in the vaccinated dialysis group, −28% in the control group (p < 0.001) and +48% in dialysis patients who had been infected with COVID-19 (p < 0.001). A non-responder status at 6 months was associated with a lower albumin level. No serious adverse events following vaccination were reported. In conclusion: the initially high response rate to the BNT162b2 vaccine in dialysis patients decreases rapidly. Our results indicate that an early booster (3rd) dose, at three months after the second dose, may be advised for this population to preserve the humoral immunity.

Vinblastine fails to improve response of renal cancer to interferon alfa-n1: high response rate in patients with pulmonary metastases.

1991 ◽  
Vol 9 (5) ◽  
pp. 832-836 ◽  
Author(s):  
J A Neidhart ◽  
S A Anderson ◽  
J E Harris ◽  
J J Rinehart ◽  
J Laszlo ◽  
...  
Keyword(s):  
Response Rate ◽  
Complete Response ◽  
High Response Rate ◽  
Interferon Alfa ◽  
Induction Treatment ◽  
Small Subset ◽  
Research Triangle ◽  
Significant Difference ◽  
To Receive ◽  
Better Than

One hundred sixty-five patients were randomized to receive either interferon alfa-n1 (Wellferon; Burroughs Wellcome Co, Research Triangle Park, NC) alone or with vinblastine. An initial six-cycle induction treatment consisted of interferon given at daily doses of 3, 5, 20, 20, and 20 x 10(6) U/m2 every 2 weeks. Vinblastine at a dose of 10 mg/m2 (later decreased to 5 mg/m2) was given on day 1 of alternate cycles. Toxicities were generally well tolerated. The overall response rate was 10% with no significant difference between treatment arms. Survival was also not significantly different for the arms. A small subset of patients (16) with metastases only to the lungs had a high complete response (CR) and partial response (PR) rate of 44%. Responses were durable, and overall survival of this group was much better than that of the other patients.

scholarly journals Efficacy of Ruxolitinib in Patients With Chronic Neutrophilic Leukemia and Atypical Chronic Myeloid Leukemia

2020 ◽  
Vol 38 (10) ◽  
pp. 1006-1018 ◽  
Author(s):  
Kim-Hien T. Dao ◽  
Jason Gotlib ◽  
Michael M.N. Deininger ◽  
Stephen T. Oh ◽  
Jorge E. Cortes ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Adverse Events ◽  
Myeloid Leukemia ◽  
Response Rate ◽  
Symptom Assessment ◽  
Complete Response ◽  
Serious Adverse Events ◽  
Chronic Neutrophilic Leukemia ◽  
Atypical Chronic Myeloid Leukemia ◽  
Grade 3

PURPOSE Colony-stimulating factor-3 receptor ( CSF3R)-T618I is a recurrent activating mutation in chronic neutrophilic leukemia (CNL) and to a lesser extent in atypical chronic myeloid leukemia (aCML) resulting in constitutive JAK-STAT signaling. We sought to evaluate safety and efficacy of the JAK1/2 inhibitor ruxolitinib in patients with CNL and aCML, irrespective of CSF3R mutation status. METHODS We conducted a phase II study of ruxolitinib in 44 patients (21 CNL and 23 aCML). The primary end point was overall hematologic response rate (ORR) by the end of 6 continuous 28-day cycles for the first 25 patients enrolled. We considered a response as either partial (PR) or complete response (CR). We expanded accrual to 44 patients to increase our ability to evaluate secondary end points, including grade ≥ 3 adverse events, spleen volume, symptom assessment, genetic correlates of response, and 2-year survival. RESULTS ORR was 32% for the first 25 enrolled patients (8 PR [7 CNL and 1 aCML]). In the larger cohort of 44 patients, 35% had a response (11 PR [9 CNL and 2 aCML] and 4 CR [CNL]), and 50% had oncogenic CSF3R mutations. The mean absolute allele burden reduction of CSF3R-T618I after 6 cycles was greatest in the CR group, compared with the PR and no response groups. The most common cause of death is due to disease progression. Grade ≥ 3 anemia and thrombocytopenia were observed in 34% and 14% of patients, respectively. No serious adverse events attributed to ruxolitinib were observed. CONCLUSION Ruxolitinib was well tolerated and demonstrated an estimated response rate of 32%. Patients with a diagnosis of CNL and/or harboring CSF3R-T618I were most likely to respond.

Autologous Stem Cell Transplantation (ASCT) Versus Standard Treatments for CLL Patients: First Interim Analysis of a Prospective Randomized Study from the French Cooperative Study Group on CLL.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5471-5471 ◽  
Author(s):  
Laurent Sutton ◽  
Marine Diviné ◽  
Philippe Travade ◽  
Claude Martin ◽  
Stéphane Leprêtre ◽  
...  
Keyword(s):  
Stem Cells ◽  
Hemolytic Anemia ◽  
Interim Analysis ◽  
Response Rate ◽  
Randomized Study ◽  
Virus Reactivation ◽  
Cooperative Study Group ◽  
Mutational Status ◽  
Binet Stage ◽  
The Impact

Abstract Patients with stage B or C CLL, under 66 years, previously untreated are included in this trial. They are scheduled to receive 3 monthly courses of mini-CHOP (3mC) followed by 3 monthly courses of Fludarabine (3F) before evaluation of the response. Patients in complete response (NCI) undergo stem cells mobilisation with G-CSF alone, then are randomized between ASCT and observation. Patients not in CR receive 1 or 2 courses of DHAP for mobilisation of stem cells and are randomized between ASCT or 3 monthly courses of Fludarabine/Cytoxan (F/C). The primary endpoint in this study is EFS at 3 years. This first interim analysis was planed after the randomisation of the first 100 patients (6 October 2004). At that time, 142 patients have been included. Among them, 16 have not completed yet the full treatment before randomization; 26 were not randomized because of early death (9), erroneous inclusion (3), autoimmune hemolytic anemia (2), cytopenia (2), investigator’s or patient’s decision (10). From these 26 patients, 14 were nevertheless assessable for response after they received 3mC+3F (1 CR, 4 PR, 2 SD, 7 PD), 6 failed and 6 were not evaluable for response. For each included patient, cytology, flow cytometry, cyclin D1 expression and biological pronostic factors (cytogenetics, IgVH, mutational status, ZAP70 expression) were centrally reviewed. At baseline, 110 patients were in Binet stage B and 32 in Binet stage C. Median age at inclusion was 55 years (min: 31, max: 65). After the six monthly courses (3mC+3F), overall response (CR + PR) was 82.5% (99/120 patients); 49 patients were in CR (41%) from which 48 were randomized between observation and ASCT. 52 patients, not in CR, (46 PR, 5 SD, 1 PD) were randomized between ASCT and F/C. After randomisation, 9 patients died from refractory disease (6), pneumonia (3), neither after ABMT. Two patients had prolonged pancytopenia: one after ASCT who was further allografted and one after F/C. Four patients experienced a Richter syndrome, 3 before ASCT, 1 in the observation arm. Two patients developed hemolytic anemia (one after DHAP, one after the first course of F/C). One patient had hepatitis B virus reactivation 6 months after ASCT. This study is ongoing until randomization of 208 patients. These preliminary results show that in advanced stage CLL (B and C Binet stages) the 3mC+3F regimen displays a very good response rate, which compares favorably with the best published ones. The study of the impact of pronostic biological parameters on response rate is on progress and will be presented at the meeting.

A Single-Center Study To Evaluate the Safety and Efficacy of Intravenous/Oral Fludarabine in Untreated Gastric MALT Lymphoma. Impact of t(11;18)(q21;q21) in Molecular Response Rates.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4439-4439
Author(s):  
Antonio Salar ◽  
Beatriz Bellosillo ◽  
Agustín Seoane ◽  
Luz Martinez ◽  
Ana Ferrer ◽  
...  
Keyword(s):  
Malt Lymphoma ◽  
Response Rate ◽  
Single Agent ◽  
Active Agent ◽  
Hematological Toxicity ◽  
Clinical Activity ◽  
Gastric Malt Lymphoma ◽  
Molecular Response ◽  
Sequencing Analysis

Abstract Background: The treatment of gastric mucosa-associated lymphoid tissue (MALT) lymphoma in the absence of H. pylori infection or when the lymphoma fails to regress after adequate antibiotic treatment remains controversial. Fludarabine (F) is an active agent for indolent lymphoma, however, its clinical activity in gastric MALT lymphoma has not been studied. The aim of the study is to assess the efficacy and safety of single-agent fludarabine in gastric MALT lymphoma and to analyze the molecular response (MR) after this treatment. Methods: Treatment consisted of fludarabine (25 mg/m2 IV) given on days 1–5, every 4 weeks, for 6 cycles; after the first cycle, oral fludarabine was allowed to be given orally at 40 mg/m2 with the same schedule. Molecular response (MR) was assessed by RT-PCR analysis of t(11;18) or by PCR assays for analysis of IgH gene rearrangements analyzing FR1, FR2 and FR3 in endoscopic biopsies. Results: Eight consecutive patients were included. Median age: 60 years (range: 45–77); 3 pts were in stage I, 2 stage II-1 and 3 stage IV according to Lugano system. Four out of 5 (80%) pts achieved a CR after three cycles and all eight cases (100%) achieved a CR after six cycles, for an overall response rate of 100%. After a median follow-up of 44 months (range 14.5–58 mo) no patient has shown clinical or endoscopic relapse. Hematological toxicity occurred in 75% of pts, mainly mild neutropenia and generally after the third cycle. Three cases received G-CSF (after the 2nd, 3rd and 6th cycle) and three patients required dose modification or delay (3–7 days) in the delivery of the following cycle. No blood transfusions were required. Only one patient had to be admitted because of non-neutropenic fever. None case of myelodisplasia has been detected at last follow-up. Four out of 8 pts (50%) achieved MR during the study-period (see figure). Four out of 5 (80%) pts without t(11;18) achieved MR. In contrast, no patient carrying t(11;18) achieved MR. Sequencing analysis of monoclonal PCR products will be presented. Conclusions: Fludarabine, either intravenous or oral, is safe and achieve a high response rate when given in gastric MALT lymphoma, with many pts achieving MR. In those pts carrying t(11;18), residual disease can be detected by PCR but do not determine relapse at present follow-up. Figure Figure

A prospective study investigating the impact of definitive chemoradiation in locoregionally advanced squamous cell carcinoma of the skin.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8538-8538 ◽  
Author(s):  
Michelle K. Nottage ◽  
Alessandra Bastian Francesconi ◽  
Kathleen Emilie Mary Houston ◽  
Charles Lin ◽  
Lizbeth M. Kenny ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Response Rate ◽  
Complete Response Rate ◽  
Squamous Cell Cancer ◽  
Performance Status ◽  
Cell Cancer ◽  
Prospective Trial ◽  
Complete Response ◽  
Platinum Based Chemotherapy ◽  
The Impact

8538 Background: Our state, Queensland, Australia, has the highest rate of cutaneous squamous cell cancer (SCC) in the world. Spread to regional lymph nodes or more distant sites occurs in 5-10%. A proportion of patients can not undergo surgical resection but complete response rates with radiotherapy alone are low. This led to the hypothesis that combined chemoradiation (CRT) may be of benefit. We decided to document the outcomes of concurrent chemoradiation by means of a prospective trial. Methods: This was a single arm, phase II study with planned sample size 30 patients. The primary endpoint was complete response rate (CRR), estimate 60%. Patients with locally/regionally advanced (non-metastatic) cutaneous SCC deemed unresectable or unsuitable for surgery by consensus of the multidisciplinary Head and Neck Cancer Clinic, with measurable disease, aged over 18, performance status 0-2, received definitive radiotherapy (XRT) (70Gy in 35#) and concurrent weekly platinum based chemotherapy (CT) (cisplatin 40mg/m2 or carboplatin AUC 2). Results: 14 patients were enrolled (Feb 2008-June 2011), median age 66 (48-84), 64% ECOG PS 0, 64% stage IV, 57% nodal disease only. Cisplatin/carboplatin was administered in 64%/36% respectively. 42% received all planned CT while 58% had 1 or 2 weeks omitted. 2 patients had dose reductions. XRT was completed as planned in 93%. The CRR was 57% (8/14) at analysis in December 2011 (median follow-up 13.5m). 2 further patients with partial response (PR) achieved CR after undergoing salvage surgery. Six (43%) patients had a PR; 4(29%) did not receive surgery and later progressed. Median overall survival was not reached, with 3 year survival 54%. The most frequent toxicities were dermatitis, mucositis, thrombocytopenia, nausea, anaemia, dysphagia. 28% had grade 3/4 toxicity, mainly cytopenias, infection, dehydration and nausea. Conclusions: This is the only prospective series of CRT for cutaneous squamous cell cancer. A high complete response rate was documented in patients with loco-regionally advanced disease and multiple co-morbidities, with acceptable toxicity, making this a reasonable alternative for patients unable to undergo surgery.

Triplet chemotherapy (TC) with FOLFIRINOX regimen in metastatic colorectal cancer (mCRC): Experience of the Val d’Aurelle Center.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3633-3633
Author(s):  
Emmanuelle Samalin ◽  
Virginie Loriot ◽  
Simon Thézenas ◽  
Eric Assenat ◽  
Fabienne Portales ◽  
...  
Keyword(s):  
Overall Survival ◽  
Liver Metastases ◽  
Targeted Therapies ◽  
Primary Tumor ◽  
Response Rate ◽  
Objective Response ◽  
Complete Response ◽  
Median Number ◽  
Grade 3 ◽  
The Impact

3633 Background: TC is a treatment option for mCRC to improve the tumor response rate in selected patients (pts) and the conversion rate of initially non-resectable liver metastases. The aim of this study was to evaluate the impact and feasibility of FOLFIRINOX regimen in mCRC pts. Methods: All mCRC pts with non-resectable disease who have received FOLFIRINOX alone or combined with targeted therapies (bevacizumab or cetuximab) from October 2000 to December 2010 were selected for this analysis. Clinical data were collected in a mCRC specific data base and analyzed by the end of 2011. Results: Ninety two pts (52% of men), median age 59 yrs (range: 27-76) were treated with FOLFIRINOX (D1 oxaliplatin 85 mg/m² IV 2H then irinotecan 180 mg/m² IV 90 min and elvorin 200 mg/m², then 5FU 200 mg/m² and 2400 mg/m² by 46H infusion, D1=D15) alone (64%) or combined with cetuximab(30%) or bevacizumab (6%), as 1st-line in 82 pts (89%). Prophyllactic G-CSF was given in 58% of them. Primary tumor was located in colon (58%) or rectum (42%), and 64 (69%) of pts presented with synchronous metastases: liver 100%, lung 40%, peritoneum 17% and nodes 17%. Median number of cures was 8 (range: 1-12). There was 1 toxic death. Grade 3-4 toxicities were: diarrhea 22%, neuropathy 21%, cutaneous 12%, neutropenia 28%, febrile neutropenia 0%, thrombopenia 6%. Objective Response rate according to RECIST criteria was 72% [CI95% 61-81] including 10 pts with complete response (11%). The primary tumor was resected in 70 pts (76%) and 14% had KRAS mutated tumor. Among the pts with liver metastases, 63 (68%) pts were evaluated for secondary resectability by a multidisciplinary committee and 40 pts (43%) had resection achieved (70% R0). Median overall survival was 49 months [CI95%28-62]. Conclusions: These results confirm the feasibility of FOLFIRINOX regimen with or without targeted therapies and its efficacy in terms of response rate and overall survival as 1rst-line treatment in selected mCRC pts.

Final results of a phase II trial of weekly nab-paclitaxel with GM-CSF as chemoimmunotherapy for platinum-resistant epithelial ovarian cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5082-5082
Author(s):  
Ron E. Swensen ◽  
Barbara Ann Goff ◽  
Jennifer Childs ◽  
Doreen Higgins ◽  
Theodore Gooley ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Tumor Immunity ◽  
Response Rate ◽  
Complete Response ◽  
High Response Rate ◽  
Time To Progression ◽  
Fallopian Tube Cancer ◽  
Power Estimate ◽  
Gm Csf ◽  
Platinum Resistant

5082^ Background: Ovarian cancer patients with an anti-tumor immune response have a prolonged survival, suggesting that augmenting anti-tumor immunity may be therapeutic. We hypothesized that weekly nab paclitaxel (nabP) followed by GM-CSF may enhance anti tumor immunity and prolong time to progression (TTP). Methods: Eligible subjects had platinum resistant ovarian, primary peritoneal or fallopian tube cancer, and an elevated CA125. Conditional power estimate after 11 subjects showed 22 subjects had 80% power to show a response rate (RR) >21% if the true study RR is 35%. Study end points were RR and TTP. Progression (DP) was doubling of CA125 above the nadir. Complete response (CR) was a decline of CA125 below institutional normal. Partial response (PR) was a decline of >50% from baseline. Stable disease (SD) was all other scenarios. Subjects received nabP, 100mg/m2 days 1,8,15 followed by GM-CSF 250mcg days 16-26 of a 28 day cycle until progression or 6 cycles were complete. Responding subjects received up to 6 more cycles of GM-CSF on days 14-28. Results: 21 subjects received at least one dose of study medications. Median age was 61 (30-91) and had a median of 3 (1-13) prior regimens. Among those completing the study, the median TTP was 132 days vs. 272 days on the prior platinum regimen. 9/21 (43%) had a PR and 4/21 (19%) had a CR. Subjects with a response had a median TTP of 140 days. Assay of serial T-lymphocyte counts against CEA, MUC1, CA125 and tt and influenza controls are planned. Conclusions: Weekly nabP with GM-CSF had manageable toxicity and induced a high response rate (62% by CA125) in patients with platinum resistant ovarian cancer, however this regimen did not prolong the TTP beyond the TTP observed in the prior platinum regimen.

Triplet chemotherapy (TC) with FOLFIRINOX regimen in metastatic colorectal cancer (mCRC): Experience of two French centres.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 776-776 ◽  
Author(s):  
Emmanuelle Samalin ◽  
Christelle De La Fouchardiere ◽  
Simon Thézenas ◽  
Matthieu Sarabi ◽  
Eric Assenat ◽  
...  
Keyword(s):  
Response Rate ◽  
Primary Tumour ◽  
Objective Response ◽  
Tumour Response ◽  
Complete Response ◽  
Median Number ◽  
R0 Resection ◽  
Secondary Resection ◽  
Grade 3 ◽  
The Impact

776 Background: TC is a treatment option for mCRC to improve the tumour response rate in selected patients (pts) and the conversion rate of initially nonresectable liver metastases. The aim of this study was to evaluate the impact and feasibility of FOLFIRINOX regimen in mCRC pts. Methods: We selected all mCRC pts from the ICM and CLB French centres with unresectable disease treated from October 2000 to May 2012 with FOLFIRINOX alone or combined with bevacizumab or cetuximab. Clinical data were collected in a mCRC-specific data base and analysed. Results: 159 pts (52% of men), median age 58 yrs (range: 24-76) were treated with FOLFIRINOX (D1 oxaliplatin 85 mg/m² IV over 2H, then irinotecan 180 mg/m² IV over 90 min and elvorin 200 mg/m², then 5-fluorouracile 200 mg/m² and 2,400 mg/m² IV over 46H, D1=D15) alone (68%) or combined with cetuximab (24%) or bevacizumab (8%) as first–line treatment (88%). Primary tumour was located in colon (77%) or rectum (23%), and 134 pts (84%) presented with synchronous metastases: liver (96%), lung (46%), peritoneum (11%) and nodes (20%). Median number of courses was 8 (range: 1-26). There was 1 toxic death. Grade 3-4 toxicities were as follows: diarrhoea (23%), neuropathy (24%), cutaneous (9%), neutropenia (21%), febrile neutropenia (1%), thrombopenia (4%). Objective response rate according to RECIST V1.0 was 72% [95% CI: 65-79] including 12 pts with complete response. The primary tumour was resected in 127 pts (79%) and 19% had KRAS mutated tumour. Among the 105 pts (66%) with initially non-resectable liver-limited disease (LLD), 59 pts (56%) were eligible for secondary resection and a R0 resection rate was achieved for 44 pts. Median overall survival was 49 months [95% CI: 37-62] and 72 months [95% CI: 48-84] in resected LLD population. Conclusions: These results confirm the feasibility of FOLFIRINOX regimen with or without targeted therapies and its efficacy in LLD selected mCRC population.

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