scholarly journals Benefits of Etoposide Maintenance Therapy for Patients With Extensive SCLC Who Experienced PR/CR/SD After 4-6 Cycles of First-Line Chemotherapy With Etoposide Plus Cisplatin/Carboplatin

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 229s-229s
Author(s):  
Z. He ◽  
C. Zhang ◽  
Q. Wang ◽  
C. Xu
Keyword(s):  
Treatment Group ◽  
Maintenance Therapy ◽  
Maintenance Treatment ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Group A ◽  
Group B ◽  
Line Chemotherapy

Background: The clinical remission period of small cell lung cancer was shorter after the first-line treatment. Aim: To observe whether oral etoposide maintenance therapy can improve the progression-free survival (PFS) in patients with lung cancer who experienced complete remission (CR), partial remission (PR), and disease stabilization (SD) after 4-6 cycles of first-line chemotherapy with etoposide plus cisplatin/carboplatin. Methods: A retrospective analysis was performed on patients with ED-SCLC who were treated with etoposide (100 mg/d, iv.gtt days 1-5 with a cycle length of every 21 days) plus 4-6 cycles of cisplatin/carboplatin chemotherapy during the period from 1 January 2014 to 31 December 2016 at the Cancer Hospital affiliated with Zhengzhou University. All the patients were divided into 2 groups based on the criteria whether they had gone through maintenance therapy with etoposide: nonmaintained treatment group (NT), and maintenance treatment group (TH). The maintenance treatment group was further subdivided into the 25 mg subgroup (group A) and the 50 mg subgroup (group B) according to the maintenance dose. Analysis of 1-year progression-free survival (PFS) was conducted using the Kaplan-Meier method and Cox proportional hazards model. PFS1 was defined as the first day of first-line treatment until the disease progressed or the last follow-up time. PFS2 was defined as the first day of etoposide capsule treatment until disease progression or the last follow-up time. Results: A total of 85 patients were enrolled in this study; there were 50 patients in the NT group (58.8%) and 35 patients in the TH group (41.2%). In the TH group, there were 10 (28.6%) in the 25 mg subgroup (group A) and 25 (71.4%) in the 50 mg subgroup (group B). Detailed patient information and tumor-related parameters are shown in Table 1. For all patients, the median PFS1 in the first-line regimen with either the cisplatin or carboplatin group was 6.5 months (95% CI: 5.870-7.130) and 6.4 months (95% CI: 5.970-6.970) respectively ( P = 0.0551). Median progression-free survival for all patients and the median PFS for patients of the TH group were 6.5 months (95% CI: 6.138-6.861) and 7.2 months (95% CI: 6.702-7.698) respectively; the median PFS for the NT group, subgroup A, and subgroup B were 5.7 months (95% CI: 4.862-6.478), 6.7 months (95% CI: 6.390-7.010), and 7.4 months (95% CI: 6.386-8.474), respectively ( P = 0.0043). Median PFS2 was 2.400 months for maintenance treatment patients; the median PFS2 in the 25 mg and 50 mg groups was 2.100 months (95% CI 1.690-2.510 months) and 3.030 months (95% CI 1.937-4.123 months), respectively ( P = 0.0309). Conclusion: Use of etoposide capsules to maintain chemotherapy can significantly prolong the progression-free survival (PFS) of CR, PR, and SD in patients with extensive SCLC and improve 1-year survival; a 50-mg dose is better than 25 mg.

Incorporation of Pazopanib in Maintenance Therapy of Ovarian Cancer

2014 ◽  
Vol 32 (30) ◽  
pp. 3374-3382 ◽  
Author(s):  
Andreas du Bois ◽  
Anne Floquet ◽  
Jae-Weon Kim ◽  
Joern Rau ◽  
Josep M. del Campo ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Growth Factor ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Growth Factor Receptor ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Line Chemotherapy

PurposePazopanib is an oral, multikinase inhibitor of vascular endothelial growth factor receptor (VEGFR) -1/-2/-3, platelet-derived growth factor receptor (PDGFR) -α/-β, and c-Kit. Preclinical and clinical studies support VEGFR and PDGFR as targets for advanced ovarian cancer treatment. This study evaluated the role of pazopanib maintenance therapy in patients with ovarian cancer whose disease did not progress during first-line chemotherapy.Patients and MethodsNine hundred forty patients with histologically confirmed cancer of the ovary, fallopian tube, or peritoneum, International Federation Gynecology Obstetrics (FIGO) stages II-IV, no evidence of progression after primary therapy consisting of surgery and at least five cycles of platinum-taxane chemotherapy were randomized 1:1 to receive pazopanib 800 mg once per day or placebo for up to 24 months. The primary end point was progression-free survival by RECIST 1.0 assessed by the investigators.ResultsMaintenance pazopanib prolonged progression-free survival compared with placebo (hazard ratio [HR], 0.77; 95% CI, 0.64 to 0.91; P = .0021; median, 17.9 v 12.3 months, respectively). Interim survival analysis based on events in 35.6% of the population did not show any significant difference. Grade 3 or 4 adverse events of hypertension (30.8%), neutropenia (9.9%), liver-related toxicity (9.4%), diarrhea (8.2%), fatigue (2.7%), thrombocytopenia (2.5%), and palmar-plantar erythrodysesthesia (1.9%) were significantly higher in the pazopanib arm. Treatment discontinuation related to adverse events was higher among patients treated with pazopanib (33.3%) compared with placebo (5.6%).ConclusionPazopanib maintenance therapy provided a median improvement of 5.6 months (HR, 0.77) in progression-free survival in patients with advanced ovarian cancer who have not progressed after first-line chemotherapy. Overall survival data to this point did not suggest any benefit. Additional analysis should help to identify subgroups of patients in whom improved efficacy may balance toxicity (NCT00866697).

Oligometastasiertes nicht kleinzelliges Lungenkarzinom: Vorteile einer lokalen Konsolidierungstherapie nutzen

2019 ◽  
Vol 7 (6) ◽  
pp. 312-313
Author(s):  
Wolfgang Schütte ◽  
Miriam Möller
Keyword(s):  
Adverse Events ◽  
Maintenance Therapy ◽  
Systemic Therapy ◽  
Maintenance Treatment ◽  
Therapy Group ◽  
Progression Free Survival ◽  
Cancer Center ◽  
First Line ◽  
Free Survival ◽  
Md Anderson

Background: Evidence from retrospective studies suggests that disease progression after first-line chemotherapy for metastatic non-small-cell lung cancer (NSCLC) occurs most often at sites of disease known to exist at baseline. However, the potential effect of aggressive local consolidative therapy for patients with oligometastatic NSCLC is unknown. We aimed to assess the effect of local consolidative therapy on progression-free survival. Methods: In this multicentre, randomised, controlled, phase 2 study, eligible patients from three hospitals had histological confirmation of stage IV NSCLC, three or fewer metastatic disease lesions after first-line systemic therapy, an Eastern Cooperative Oncology Group performance status score of 2 or less, had received standard first-line systemic therapy, and had no disease progression before randomisation. First-line therapy was four or more cycles of platinum doublet therapy or 3 or more months of EGFR or ALK inhibitors for patients with EGFR mutations or ALK rearrangements, respectively. Patients were randomly assigned (1:1) to either local consolidative therapy ([chemo]radiotherapy or resection of all lesions) with or without subsequent maintenance treatment or to maintenance treatment alone, which could be observation only. Maintenance treatment was recommended based on a list of approved regimens, and observation was defined as close surveillance without cytotoxic treatment. Randomisation was not masked and was balanced dynamically on five factors: number of metastases, response to initial therapy, CNS metastases, intrathoracic nodal status, and EGFR and ALK status. The primary endpoint was progression-free survival analysed in all patients who were treated and had at least one post-baseline imaging assessment. The study is ongoing but not recruiting participants. This study is registered with ClinicalTrials.gov, number NCT01725165. Findings: Between Nov 28, 2012, and Jan 19, 2016, 74 patients were enrolled either during or at the completion of first-line systemic therapy. The study was terminated early after randomisation of 49 patients (25 in the local consolidative therapy group and 24 in the maintenance treatment group) as part of the annual analyses done by the Data Safety Monitoring Committee of all randomised trials at MD Anderson Cancer Center, and before a planned interim analysis of 44 events. At a median follow-up time for all randomised patients of 12·39 months (IQR 5·52-20·30), the median progression-free survival in the local consolidative therapy group was 11·9 months (90% CI 5·7-20·9) versus 3·9 months (2·3-6·6) in the maintenance treatment group (hazard ratio 0·35 [90% CI 0·18-0·66], log-rank p=0·0054). Adverse events were similar between groups, with no grade 4 adverse events or deaths due to treatment. Grade 3 adverse events in the maintenance therapy group were fatigue (n=1) and anaemia (n=1) and in the local consolidative therapy group were oesophagitis (n=2), anaemia (n=1), pneumothorax (n=1), and abdominal pain (n=1, unlikely related). Interpretation: Local consolidative therapy with or without maintenance therapy for patients with three or fewer metastases from NSCLC that did not progress after initial systemic therapy improved progression-free survival compared with maintenance therapy alone. These findings suggest that aggressive local therapy should be further explored in phase 3 trials as a standard treatment option in this clinical scenario. Funding: MD Anderson Lung Cancer Priority Fund, MD Anderson Cancer Center Moon Shot Initiative, and Cancer Center Support (Core), National Cancer Institute, National Institutes of Health.

Thalidomide Based Regimens (TBR) for Relapsed/Refractory Multiple Myeloma Patients: Long Term Follow Up, Unmaintained Remissions and Disease Control after Subsequent Treatments.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4812-4812
Author(s):  
Maria Roussou ◽  
Efstathios Kastritis ◽  
Athanasios Anagnostopoulos ◽  
Evangelos Eleftherakis-Papaiakovou ◽  
Charis Matsouka ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Progression Free Survival ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up ◽  
Group A ◽  
Pulse Dexamethasone ◽  
Group B

Abstract Introduction: The effectiveness of thalidomide based regimens (TBR) in patients with relapsed/refractory multiple myeloma is well established. However, there are still limited data regarding the long term follow up after such regimens and the outcome of patients when they progress and they receive further treatment. In order to answer these questions we evaluated a series of 114 patients with relapsed/refractory multiple myeloma who were treated with TBR. None of these patients had previously received thalidomide, bortezomib or lenalidomide. Patients and Methods: All patients were treated with thalidomide and dexamethasone with or without other oral agents. More specifically 41 patients had received continuous thalidomide and pulse dexamethasone, 25 patients clarithromycin, continuous thalidomide and pulse dexamethasone, 43 patients intermittent thalidomide, pulse dexamethasone and cyclophosphamide and 5 patients continuous thalidomide, pulse dexamethasone and cyclophosphamide. Type of treatment at the time of progression after TBR, response to this treatment and progression free survival were recorded for each patient. Moreover, patients who received novel agents after progression to TBR, were divided into 2 subgroups, according to their resistance to thalidomide. In group A, patients had refractory or progressive myeloma while on TBR or within 2 months after discontinuation of TBR. In group B, myeloma progressed more than 2 months after discontinuation of TBR. Results: Among the 114 patients, 41 had not responded to TBR and 73 (64%) had achieved at least a partial response. The median PFS for all patients was 8 months. As of June 2007, 10 patients remain without progression from 28 to 81 months (median 54 months). Eight patients remain off treatment and without progression for a median of 56 months (range 28–81). Patients who did not respond to or progressed after TBR were analyzed for further treatment and outcome. Thirty eight patients (37%) died before receiving further treatment, 23 patients (23%) received conventional chemotherapy and 41 patients (40%) received continuous thalidomide and dexamethasone +/− clarithromycin or cyclophosphamide (17 patients), bortezomib and dexamethasone (7 patients), melphalan-bortezomib-dexamethasone and intermittent thalidomide (12 patients) or lenalidomide with dexamethasone (5 patients). Among these 41 patients, 24 were classified in group A (thalidomide resistant) and 17 in group B. Overall 17 (41%) achieved at least partial response after retreatment with novel agent-based regimens. A response was observed in 46% of patients in group A and in 35% of patients in group B. The median progression free survival of the 41 patients who received retreatment with novel agents was 9.2 months and the median survival was 17 months. Among the 23 patients who received conventional chemotherapy only five (21%) patients responded and the progression free survival and the median survival were 5.3 and 10.2 months, respectively. Conclusions: After an oral TBR regimen 6 (5%) patients remain without treatment and free of progression for more than 4 years. A significant number of patients who progressed after TBR and who received further treatment which included a novel agent achieved a response, including several patients who were resistant to TBR.

scholarly journals Lenalidomide in Combination with Standard R-CHOP Overcomes the Negative Prognostic Value of Peripheral Blood Absolute Lymphocyte/Monocyte Ratio at Diagnosis and during Treatment in Patients with Diffuse Large B-Cell Lymphoma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4139-4139
Author(s):  
Alessia Castellino ◽  
Levy D. Pederson ◽  
Kay M. Ristow ◽  
Christina Stenzel ◽  
Betsy Laplant ◽  
...  
Keyword(s):  
Treatment Group ◽  
Tumor Microenvironment ◽  
Prognostic Value ◽  
De Novo ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Free Survival ◽  
Group A ◽  
Group B ◽  
Group D

Abstract Introduction. The peripheral blood absolute lymphocyte (ALC)/monocyte (AMC) ratio (ALC/AMC), as a surrogate of host immunity (i.e. ALC) and tumor microenvironment (i.e. AMC), is a predictive biomarker for clinical outcomes in diffuse large B-cell (DLBCL) patients. An ALC/AMC ratio ≥ 1.1 has been shown to be predictive of better survival both at baseline and during each therapy cycle in patients treated with R-CHOP [Porrata et al, 2014]. Lenalidomide is an immunomodulatory drug, effective in DLBCL patients, with various mechanisms of actions on the tumor microenvironment and the host immune response. In this study we analyze the prognostic value of ALC/AMC ratio in a cohort of newly diagnosed DLBCL patients treated with Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, R2-CHOP) in a phase II trial (MC078E trial, [Nowakowski et al, 2015]). Methods. All patients with de-novo DLBCL enrolled in the phase II trial MC078E and treated at diagnosis with R2-CHOP regimen were included in the analysis. We investigated the ALC/AMC ratio at baseline and each R2-CHOP cycle as predictor of progression-free survival (PFS) and overall survival (OS). The ALC/AMC ratio was obtained by dividing the ALC by the AMC from the automated white blood cell differential obtained from the complete blood cell count on day 0 of each treatment cycle (range from day -3 to day 0 of each course). Patients were then divided in 4 groups on the basis of pattern of ALC/AMC ratio during treatment: group A: patients with ALC/AMC ratio ≥ 1.1 throughout all cycles; group B: patients with ALC/AMC ratio ≥ 1.1 at baseline, but then obtained an ALC/AMC < 1.1 during treatment; group C: patients with ALC/AMC ratio < 1.1 at baseline, but then gained an ALC/AMC ≥ 1.1 during treatment; group D: patients with ALC/AMC ratio < 1.1 throughout all cycles. PFS and OS were analyzed in the different groups. We separately conducted the same analysis in a matched control cohort of 94 DLBCL patients from the Mayo Clinic Lymphoma Database treated with standard R-CHOP. Results. A total of 63 patients with de-novo DLBCL treated with R2CHOP regimen at diagnosis were included in the analysis. Clinical characteristics were: median age 67 years (22-87), male sex 61.9%, III-IV advance stage 87.3%, elevated LDH serum levels 66.7%, intermediate-high/high International Prognostic index (IPI) score in 54% cases. No differences in 3y-PFS and 3y-OS in patients with ALC/AMC ratio ≥ 1.1 vs ALC/AMC < 1.1 at baseline and at each R2-CHOP course have been observed. In a landmark analysis from day 0 of the last cycle, 3y-PFS in group A vs B vs C vs D was: 71.4% vs 67.1% vs 66.7% vs 85.7%, respectively (p 0.80); 3y-OS in group A vs B vs C vs D was: 85.7% vs 86.5% vs 66.7% vs 100%, respectively (p 0.74). No differences in both 3y-PFS and 3y-OS were observed comparing group A vs B, in group C vs D, and in group A vs D. Unlike what was observed in the R-CHOP treated DLBCL patients, in a univariate analysis ALC/AMC < 1.1 during all cycles of R2CHOP was not a predictor for inferior outcomes (Figure 1.a). In the matched cohort of patients treated with standard R-CHOP, ALC/AMC < 1.1 at baseline and at each course demonstrated to be predictive of worse outcome (p <0.01),survival was significantly different in the 4 groups identified according to ALC/AMC ratio during treatment and ALC/AMC < 1.1 maintained during all cycles of R2CHOP was predictive of worse PFS and OS (Figure 1.b). Conclusions. Lenalidomide in combination with standard R-CHOP (R2-CHOP), in previously untreated DLBCL patients, appears to overcome the negative prognostic value of ALC/AMC ratio observed in patients treated with R-CHOP alone. This could reflect the additional effect of lenalidomide to standard therapy on tumor microenvironment and on host immunity response. Figure 1: Landmark Analysis for Progression Free Survival and Overall Survival by ALC/AMC groups within R2CHOP (1.A) and R-CHOP (1.B). Group A: ALC/AMC >=1.1 for all cycles; Group B: ALC/AMC >=1.1 at baseline and obtained <1.1 during treatment; Group C: ALC/AMC <1.1 at baseline and obtained >=1.1 during treatment; Group D: ALC/AMC <1.1 for all cycles. Disclosures Witzig: Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Consolidation with Alemtuzumab Improves Progression-Free Survival in Patients with Chronic Lymphocytic Leukemia (CLL) in First Remission - Long-Term Follow-Up of a Randomized Phase III Trial of the German CLL Study Group (GCLLSG).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 33-33 ◽  
Author(s):  
C. Schweighofer ◽  
M. Ritgen ◽  
B. Eichhorst ◽  
R. Busch ◽  
M. Kneba ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Phase Iii ◽  
Consolidation Therapy ◽  
First Line ◽  
Phase Iii Trial ◽  
Free Survival ◽  
To Receive ◽  
Line Chemotherapy

Abstract Purpose: Alemtuzumab (MabCampath) is a humanized monoclonal antibody that targets the CD52 antigen, which is highly expressed on most human B and T lymphocytes. Alemtuzumab has shown considerable activity in both relapsed/refractory CLL and in the frontline treatment setting. In a recent study, treatment with single-agent alemtuzumab induced MRD-negative remissions in 20% of patients with relapsed/refractory CLL (Moreton et al JCO 2005;23:2971–2979). Other studies suggest that MRD negativity can also be attained when alemtuzumab is administered as consolidation for patients with CLL who achieve incomplete initial responses to chemotherapy. Here, we report our long-term experience within a randomized phase III trial that investigates the role of alemtuzumab for consolidation therapy in patients with previously untreated CLL. Methods: Pts in complete or partial remission after induction chemotherapy, with either fludarabine (F) or fludarabine plus cyclophosphamide (FC), were randomized to receive either alemtuzumab 30 mg, 3 times a week for ≤12 wks or no further treatment. Of 21 eligible pts, who had responded to induction with F or FC (1 CR, 1 nPR, 9 PRs), 11 pts (median age: 60 years) randomized to receive alemtuzumab consolidation and 10 to the observation arm. Pts in the alemtuzumab arm received standard premedication and infection prophylaxis with famciclovir and trimethoprim/sulfamethoxazole. Results: After a median follow-up of 48 months, calculated from time of randomization within this consolidation trial, progression-free survival (PFS) was significantly improved for pts who received alemtuzumab consolidation compared to those who received no further treatment (median PFS not reached versus 20.6 months, P = 0.004). PFS from the beginning of induction therapy with F or FC is also significantly greater for patients in the alemtuzumab consolidation arm versus the observation arm. So far, 3 of 11 pts presented with disease progression after alemtuzumab consolidation compared with 8/10 progressing pts in the observation arm. Differences in PFS between both arms were not associated with disease stage before first line treatment, type of first line chemotherapy (F vs. FC) or response status before initiation of consolidation therapy (CR vs. nPR vs. PR). Correlations between achievement of MRD negative responses and PFS is still under investigation and is planned for presentation. With the exception of 2 patients (1 pt in each arm) all patients remain alive. The study was stopped prematurely due to severe infections (7 CTC III infections, which included 4 CMV reactivations, 1 CTC IV infection) in 7/11 patients being treated with alemtuzumab. However, these infections were successfully treated, not associated with the cumulative dose of alemtuzumab, and no late complications of consolidation therapy have been observed. Conclusions: Although based on few pts due to incomplete accrual, long-term PFS was significantly prolonged in patients with CLL receiving alemtuzumab consolidation after first line chemotherapy with F or FC. An ongoing phase I/II trial of the GCLLSG (CLL2i) is currently evaluating the optimal dose and schedule of alemtuzumab in CLL pts after fludarabine-based chemotherapy.

Capecitabine and oxaliplatin as first-line chemotherapy in patients with metastatic colorectal carcinoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13578-13578
Author(s):  
C. Gennatas ◽  
V. Michalaki ◽  
S. Gennatas ◽  
A. Kondi-Paphiti ◽  
D. Voros ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Complete Response ◽  
First Line ◽  
Free Survival ◽  
Life Threatening ◽  
Baseline Characteristics ◽  
Grade 3 ◽  
Unacceptable Toxicity ◽  
Line Chemotherapy

13578 Background: Capecitabine is an oral fluoropyrimidine with superior activity and safety compared with bolus 5-FU/LV in metastatic colorectal cancer (CRC). The aim of this study was to evaluate the efficacy and safety of a combination of capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced CRC. Methods: Fourty-six patients (26 men and 20 women) with metastatic CRC entered this study. All patients were treated with capecitabine (1,000mg/m2 p.o.twice daily, days 1–14) and oxaliplatin (130mg/m2 on day 1). Cycles were repeated every 21 days until disease progression or unacceptable toxicity. Baseline characteristics: Median age 61 years (range 32–74), main sites of metastasis: Liver 32 patients (70%), liver and lungs 4 patients (9%), lungs 3 patients (6%), other sites 7 patients (15%). Results: 2 patients (4%) achieved complete response (CR), 17 patients (37%) achieved partial response (PR) and 7 patients (15%) attained stable disease (SD). With a median follow-up of 22 months the progression free survival was 7.5 months and overall survival was 19.0 months. All patients were assessable for toxicities. The most commonly encountered adverse events were from the gastrointestinal system (all grades 48%, grade 3, 6%). Neither toxic death nor life-threatening febrile neutropenia were reported. Conclusions: The combination of capecitabine and oxaliplatin is a convenient regimen in patients with advanced CRC that is associated with considerable efficacy and limited toxicity. No significant financial relationships to disclose.

A randomized phase III trial of second-line chemotherapy comparing CPT-11 alone versus S-1 plus CPT-11 combination therapy in advanced gastric cancer refractory to first-line therapy with S-1 (JACCRO GC-05).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 87-87 ◽  
Author(s):  
Kazuhiro Nishikawa ◽  
Kazuaki Tanabe ◽  
Masashi Fujii ◽  
Chikara Kunisaki ◽  
Akihito Tsuji ◽  
...  
Keyword(s):  
Response Rate ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Group A ◽  
Group B ◽  
Line Chemotherapy

87 Background: In East Asia, S-1 + CDDP (SP) has been employed as first-line therapy for advanced gastric cancer (AGC) from the results of SPIRITS trial. Patients who were resistant to chemotherapy with S-1 in the first-line treatment were widely treated with taxane alone or CPT-11 alone as the second-line treatment. On the other hand, the response rate of combination therapy with S-1 is higher than that of CPT-11 alone. Then, we hypothesized that S-1 + CPT-11 prolongs survival in the second-line treatment comparing with CPT-11 alone after failure in the first-line treatment with S-1. (NCT00639327). Methods: Patients with AGC who confirmed disease progression by imaging after the first-line therapy with SP, S-1 + cocetaxel or S-1 alone except S-1 + CPT-11 were allocated into S-1 plus CPT-11 group (Group A) or CPT-11 alone group (Group B) as second-line chemotherapy. Patients who were relapsed to adjuvant chemotherapy with S-1 were not enrolled. Primary endpoint was overall survival, and secondary endpoints were progression free survival, response rate and adverse events. Results: From March 2008 to June 2011, 304 patients were enrolled, and 294 were eligible for analysis. The overall survival was 8.8 months (M) in the Group A and 9.4M in the Group B. There is no statistically significant difference in both groups (P=0.9156). The progression free survival was 4.8M in the Group A and 4.9M in the Group B (P=0.1568). The response rate was 7.6% in the Group A and 7.4% in the Group B. Grade 3 or higher leukopenia, neutropenia and febrile neutropenia were observed more frequently in the Group A than in the Group B. Conclusions: From our results, we do not recommend consecutive use of S-1 as second-line treatment in patients who are refractory to S-1 in first-line chemotherapy. Clinical trial information: 00639327.

scholarly journals Azacitidine Maintenance Versus No Maintenance after Standard Therapy in Patientswith Acute Myeloid Leukemia, a Mexican Center Experience

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 19-20
Author(s):  
Antonio De La Peña ◽  
Denisse J. Fermin-Caminero ◽  
Oscar Teomitzi-Sanchez ◽  
Luara Arana ◽  
Jose Alvarez ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Maintenance Therapy ◽  
Myeloid Leukemia ◽  
Maintenance Treatment ◽  
Progression Free Survival ◽  
Marrow Transplant ◽  
Time To Progression ◽  
Free Survival ◽  
Acute Myeloid

INTRODUCTION Achieving complete remission (CR) is an important goal for patients with acute myeloid leukemia (AML)undergoing treatment with the intent to cure. However, even after consolidation and/or hematopoieticcell transplantation (HCT), many patients will experience disease recurrence. Because of this there has long been an interest in the use of maintenance therapies after the intensive treatment phase to prolong the duration of remission and improve survival and the likelihood of cure. Although the concept of maintenance therapy in AML has been present since the 1960s, it is still a matter of controversy.Azacitidine (AZA) is a hypomethylating agent that acts by incorporating itself into DNA, reversiblyinhibiting DNA methyltransferase, thereby blocking its methylation and activating silenced tumor suppressor genes, resulting in an antitumor effect.Maintenance chemotherapy had not been able to demonstrate improvement in survival. However, in the results of the HOVON-97, Huls et al. showed a 12-month progression free survival (PFS) in 64% of older AML patients who received AZA as maintenance therapy for a maximum of 12 cycles, thus opening the door for new research in this field. OBJECTIVE To know if there is an impact of maintenance treatment with 5-Azacitidine on disease-free survival and progression-free survival, in Acute Myeloid Leukemia in complete remission, in patients who are and are not candidates for bone marrow transplant. PATIENTS AND METHODS We conducted a longitudinal, cohort, analytical, descriptive and single-center study, in the time period between January 2016 and December 2019 (designated the AZA group). Data obtained from patients receiving maintenance was compared with a historic patient cohort (designates as the no-AZA group).This study was approved by the ethics committee of CMN 20 de Noviembre. RESULTS A total of 21 patients were analyzed in the AZA group, of which 53% (n = 12) were women and 37% (n =9) were men, the median age was 54 years with a range of 19 to 65. The median of leukocytes,hemoglobin and platelets of the AZA-group at diagnosis was 22.8x109, 9.3 g/dL, and 44,000 mm3, respectively. Thirty percent had an intermediate cytogenetic risk. In the no-AZA group a total of 18 patients were analyzed, of which 73% (n=11) were female and 26% (n=7) were male, the median age was 57 years with a range of 18 to 64. The median of leukocytes, hemoglobin and platelets at diagnosis was 29.5 x109, 9.5 g/dL, and 57,000 mm3, respectively. In the no-AZA group 8% and 22% had intermediate and high cytogenetic risk, respectively. The median follow up in the no-AZA group was 32 months (10-96). The median of cycles of maintenance with AZA was 12 cycles (1-24); the follow up median, in months, was 19 (range 7-59). The response to maintenance therapy was evaluated after the completion of the first 6 treatment cycles, in which 71.4% maintained a negative minimal residual disease (MRD), and 23.8% experienced a relapse. In the no-AZA group the median time to progression was approximately 8 months, with a PFS median of 15 months; time to progression in the AZA group was approximately 15 months. At the closing of this study the AZA group has not reached the median for PFS (p=0.011) (Figure 1); 42.8% are still in maintenance therapy and in remission, 19% received a bone marrow transplant and are still in remission, 14.4% experienced relapse, 4.8% are in elective suspension of treatment and continue in remission, 9.5% are in observation and palliative care respectively CONCLUSIONS Azacitidine used as maintenance treatment in Acute Myeloid Leukemia can extend progression free survival. Disclosures De La Peña: Janssen:Speakers Bureau;Novartis:Speakers Bureau;Amgen:Speakers Bureau.Alvarez:Amgen:Speakers Bureau;Roche:Speakers Bureau;Celgene:Speakers Bureau;Novartis:Speakers Bureau;Janssen:Speakers Bureau.Perez:Novartis:Speakers Bureau;Roche:Speakers Bureau;Celgene:Speakers Bureau.Alvarado:Novartis:Speakers Bureau;Amgen:Speakers Bureau;Celgene:Speakers Bureau;Alexion:Speakers Bureau;Roche:Speakers Bureau. OffLabel Disclosure: azacitidine as maintenance for AML it is not approved yet in Mexico

Immediate and long-term results of the first line chemotherapy in patients with metastatic triple negative breast cancer. Final analysis of randomized study

2020 ◽  
pp. 75-80
Author(s):  
S.A. Lyalkin ◽  
◽  
L.A. Syvak ◽  
N.O. Verevkina ◽  
◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Randomized Study ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Group 2 ◽  
Line Chemotherapy ◽  
Group 1

The objective: was to evaluate the efficacy of the first line chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Materials and methods. Open randomized study was performed including 122 patients with metastatic TNBC. The efficacy and safety of the first line chemotherapy of regimens АТ (n=59) – group 1, patients received doxorubicine 60 мг/м2 and paclitaxel 175 мг/м2 and ТР (n=63) – group 2, patients received paclitaxel 175 мг/м2 and carboplatin AUC 5 were evaluated. Results. The median duration of response was 9.5 months (4.5–13.25 months) in patients received AT regimen and 8.5 months (4.7–12.25 months), in TP regimen; no statistically significant differences were observed, р=0.836. The median progression free survival was 7 months (95% CI 5–26 months) in group 1 and 7.5 months (95% CI 6–35 months) in group 2, p=0.85. Both chemotherapy regimens (AT and TP) had mild or moderate toxicity profiles (grade 1 or 2 in most patients). No significant difference in gastrointestinal toxicity was observed. The incidence of grade 3–4 neutropenia was higher in patients of group 2 (TP regimen): 42.8% versus 27% (р<0.05). Conclusions. Both regimens of chemotherapy (AT and TP) are appropriate to use in the first line setting in patients with metastatic TNBC. Key words: metastatic triple negative breast cancer, chemotherapy, progression free survival, chemotherapy toxicity.

scholarly journals Case report: potential treatment of metastatic amphicrine carcinoma of the rectum with FOLFOXIRI chemotherapy

2020 ◽  
Vol 2020 (11) ◽  
Author(s):  
Nobumasa Tamura ◽  
Yoshitaka Honma ◽  
Shigeki Sekine ◽  
Shunsuke Tsukamoto ◽  
Hidekazu Hirano ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
First Line ◽  
Epithelial Tumor ◽  
Carcinoma Of The Rectum ◽  
Free Survival ◽  
Lymph Nodes Dissection ◽  
Multiple Liver Metastases ◽  
Submucosal Lesion ◽  
Line Chemotherapy ◽  
Endocrine Features

ABSTRACT Amphicrine carcinoma (AmC) is a unique epithelial tumor displaying exocrine and endocrine features in the same cell. It shows an adenocarcinoma-like cellular form and has endocrine granules. There are few reports describing chemotherapy for AmC. Here, we describe a case with metastatic AmC from the rectum that was treated with FOLFOXIRI chemotherapy. A 64-year-old man was diagnosed with a submucosal lesion on the scar produced after an endoscopic mucosal resection, which had been performed for adenocarcinoma of the rectum 2 years before. The endoscopic submucosal dissection revealed AmC. The abdominoperineal resection including lymph nodes dissection was performed. Thereafter, computed tomography showed multiple liver metastases, and FOLFOXIRI was administered. The best overall response was partial response, and progression-free survival was 8.7 months. After 16.0 months since first-line chemotherapy the patient died. We can therefore conclude that FOLFOXIRI may be effective for AmC of the rectum.

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