Complete Response to Clofarabine Is Durable and Correlates with Survival in Previously Untreated Older Adult Patients with Acute Myeloid Leukemia (AML) and Unfavorable Prognostic Factors.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2061-2061 ◽  
Author(s):  
Janice Gabrilove ◽  
Stefan Faderl ◽  
Harry P Erba ◽  
David F. Claxton ◽  
M. Arellano ◽  
...  
Keyword(s):  
Overall Survival ◽  
Older Adult ◽  
Research Funding ◽  
Median Overall Survival ◽  
Disease Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Best Response ◽  
The Relationship ◽  
Disease Free

Abstract Abstract 2061 Poster Board II-38 Background: We have previously reported efficacy and safety of clofarabine in patients = 60 with at least one unfavorable prognostic factor. Retrospective analyses have suggested that survival in AML is related to quality of response. [Estey, Clinical Advances in Hematology Oncology, 2008]. In this report, we present durability and survival data for complete responders in each of the prognostic subgroups in the CLASSIC II trial, and a landmark analysis to evaluate the relationship between complete response and survival. Methods: This single arm, Phase II, open-label study enrolled adults with untreated AML =60 years old with at least one adverse prognostic factor: age =70 years, ECOG performance status (PS)=2; antecedent hematological disorder (AHD); and/or intermediate/unfavorable risk karyotype. Clofarabine was given on days 1-5 at 30 mg/m2 during induction and 20 mg/m2 during re-induction/consolidation. Primary endpoint was ORR (CR + CRp). Secondary efficacy endpoints included duration of remission (DoR), disease-free survival (DFS) and overall survival (OS). Due to interest about outcome of CR alone with respect to remission durability, such secondary endpoints were analysed and are reported below for the overall population and for each prospectively defined prognostic subgroup. Analyses of overall survival (OS) using both best response and landmark timepoints were performed. Landmark analyses eliminate survivorship bias by evaluating the robustness of the relationship between response and survival in patients who survived until a landmark timepoint and using the response at this timepoint for assessment rather than best response. Since this analysis was defined post hoc, 3 analyses of median overall survival in patients who survived at least 30, 45, and 60 days were performed to eliminate time-to-response bias. Results: 112 patients were evaluable. For patients with complete response (CR, n=42), median duration of remission (DoR) was 65 weeks (95% CI 41, not estimable [NE]), median disease free survival (DFS) 48 weeks (28, 65), and median overall survival (OS) 72 weeks (53, NE). Patients = 70 years (n=69) had 33% CR, median DoR and DFS 65 weeks (17, NE), and median OS = 48 weeks (48, NE). Patients with ECOG PS2 (n=25) had CR 24%, median DoR 7 weeks (6,NE), median DFS 9 weeks (6, 12), and median OS 16 weeks (12, 33). Patients with AHD (n= 41) had 39% CR; median DoR, DFS, and OS are NE. Patients with intermediate/unfavorable karyotype (n= 108) had 39% CR, median DoR 65 weeks (41, NE), median DFS 48 weeks (28, 65) and median OS 72 weeks (53, NE). Patients with unfavorable karyotype (n=62) had 32% CR, median DoR 56 weeks (28, NE), median DFS 33 weeks (23, 56), and median OS 59 weeks (48, NE). Median OS was 59.1 weeks (95% CI=49.9 weeks, NE) for CR + CRp; 33.4 weeks (95% CI=19.3, 55.0 weeks) for CRp; and15.4 weeks (95% CI=12.0, 29.9 weeks) for non-responders. In the landmark analysis, patients who had a complete response to clofarabine survived longer than non responders (Table 1), regardless of starting point (30, 45, or 60 days). The survival benefit of responders was statistically significant for all time points (p<0.05). Summary/conclusions: CRs were consistent, durable, and associated with survival of > 13 months in all prognostic subgroups except PS2, and complete responders lived longer than non-responders. Achievement of a CR correlates with clinical benefit and survival in older AML patients. Single agent clofarabine is an effective treatment option for older adult patients with untreated AML and unfavorable prognostic factors. Disclosures: Gabrilove: Genzyme: Research Funding. Faderl:Genzyme: Research Funding. Erba:Lilly: Research Funding; Antisoma: Research Funding; Wyeth: Research Funding; Cephalon: Honoraria, Research Funding; MGI Pharma: Honoraria; Pharmion: Honoraria; Celgene: Honoraria; BMS: Honoraria; Novartis: Honoraria, Research Funding; Genzyme: Consultancy, Honoraria, Research Funding; Gemin-X: Research Funding; Kanisa: Research Funding. Claxton:Genzyme: Research Funding. Arellano:Genzyme: Research Funding. Lyons:Celgene: Consultancy; Johnson&Johnson: Consultancy, Honoraria, Speakers Bureau; GlaxoSmithKline: Consultancy, Speakers Bureau; Amgen Inc.: Consultancy, Honoraria, Research Funding, Speakers Bureau; Genzyme: Research Funding. Kovacsovics:Genzyme: Research Funding. Eckert:Genzyme: Employment. Huebner:Genzyme: Employment. Kantarjian:Genzyme: Research Funding.

Alternating cycles of combination chemotherapy for patients with recurrent Hodgkin's disease following radiotherapy. A prospectively randomized study by the Cancer and Leukemia Group B.

1986 ◽  
Vol 4 (6) ◽  
pp. 838-846 ◽  
Author(s):  
V Vinciguerra ◽  
K J Propert ◽  
M Coleman ◽  
J R Anderson ◽  
L Stutzman ◽  
...  
Keyword(s):  
Overall Survival ◽  
Combination Chemotherapy ◽  
Hodgkin's Disease ◽  
Hodgkin’S Disease ◽  
Disease Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Group B ◽  
Leukemia Group ◽  
Disease Free

A randomized clinical trial of combination chemotherapy for patients who relapsed following primary radiation therapy for Hodgkin's disease was conducted from 1975 to 1981 by the Cancer and Leukemia Group B (CALGB). One hundred thirteen patients were prospectively randomized to receive 12 cycles of either CVPP (CCNU, vinblastine, procarbazine, and prednisone), ABOS (bleomycin, vincristine [Oncovin; Lilly, Indianapolis], doxorubicin [Adriamycin, Adria Laboratories, Columbus, Ohio], and streptozotocin), or alternating cycles of CVPP and ABOS. The median length of observation for patients in this report is 4 years. Toxicities of the three treatment programs were primarily hematologic. Frequencies of complete response were 72% for CVPP, 70% for ABOS, and 82% for CVPP/ABOS (P = .37). Females and patients who had nodular sclerosing disease at initial diagnosis had significantly higher complete response rates. The 5-year disease-free survival for the complete responders was 55%; the 5-year overall survival was 60%. There were no significant differences among the treatments on disease-free survival (P = .78) or overall survival (P = .18). Age under 40 years was the only significant positive prognostic factor for disease-free survival (P = .095) and overall survival (P = .003). This study demonstrates no statistically significant advantage for alternating cycles of combination chemotherapy in affecting complete response frequency, disease-free survival, or overall survival as compared with therapy with CVPP or ABOS alone. However, the power to detect differences in these outcome parameters is somewhat limited by the sample sizes.(ABSTRACT TRUNCATED AT 250 WORDS)

PS02.115: PERIOPERATIVE CHEMOTHERAPY VERSUS NEOADJUVANT CHEMORADIATION FOR PATIENTS WITH ADENOCARCINOMA OF THE DISTAL OESOPHAGUS IN AUSTRIA

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 153-153
Author(s):  
Oliver Koch ◽  
Andreas Tschoner ◽  
Richard Partl ◽  
Alexander Perathoner ◽  
Philipp Gehwolf ◽  
...  
Keyword(s):  
Overall Survival ◽  
Pathological Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Neoadjuvant Chemoradiation ◽  
Type I ◽  
Perioperative Chemotherapy ◽  
Free Survival ◽  
One Year ◽  
Disease Free

Abstract Background The aim of this study is to compare the outcome of patients with adenocarcinoma of the distal oesophagus (AEG Type I) treated with perioperative chemotherapy or neoadjuvant chemoradiation. Methods A retrospective analysis of eligible patients from four Austrian centers was conducted. All patients with AEG type I treated between January 2007 and October 2017 with chemotherapy (EOX-protocol) or chemoradiation (CROSS-protocol, or 5-FU/Cisplatin), followed by oesophagectomy were included in the study. Primary outcomes overall survival, and disease free survival as well as secondary outcomes, achievement of pathological complete response pCR (ypT0N0M0) or downstaging of T- or N-stage were analyzed. Primary outcomes were calculated by the Kaplan-Meier-method. Results Data of 117 patients were analyzed, 59 received chemoradiation (50/59 CROSS and 9/59 5-FU/Cisplatin) and 58 patients received perioperative chemotherapy (EOX). Complete data at time of submission were available in 40 patients in the chemoradiation group and in 37 patients in the chemotherapy group. The median follow-up time in the chemoradiation group was 13,0 months (CI 95%: 11,0–15,0) and in the chemotherapy group 45,0 months (CI 95%: 28,8–61,3). Overall survival rate in the EOX group after ½, 1, 3 and 5 years was 92%, 83%, 63% and 34%. So far long term data are not available after chemoradiation, after ½ year overall survival was 84% and after one year 60%. Disease free survival rate in the EOX group after ½, 1, 3 and 5 years was 91%, 81%, 54% and 32%, in the chemoradiation group after ½ and one year 80% and 50%. A significant difference was found in the pathological complete response (pCR) rate, it was achieved in 19% of patients after chemoradiation and in 3% after chemotherapy (P = 0000). Conclusion Concerning major response of the primary tumor there are clear advantages for chemoradiation. In regards to systemic tumor control there seems a tendency in favor for chemotherapy. Disclosure All authors have declared no conflicts of interest.

Radiotherapy Post Autologous Stem Cell Transplantation in Patients with Lymphoma Not Reached Complete Response.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5473-5473
Author(s):  
Naibai Chang ◽  
Xichun Gu ◽  
Ling Zhu ◽  
Jianping Wei ◽  
Shengming Zhao ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Disease Free Survival ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Free Survival ◽  
Disease Free

Abstract Objective: Anthracycline-based chemotherapy induces 50%–70% of CR in patients with lymphoma, but only 30%–40% of long-term disease-free survival. Salvage chemotherapy with autologous stem cell rescue is required in patients with aggressive disease or never achieve CR with conventional chemotherapy,but the relapsed rate is still high. The purpose of this study was to evaluate radiotherapy post autologous stem cell transplantation in such group of patients. Methods: 15 patients who underwent autologous stem cell transplantation during 1992–1998 were enrolled in this study. Conditioning regimen was CBV (cyclophosphomide + carmustine + etoposide). Radiotherapy was started on day +50(31–90). All patients were followed up until January 2005. Kaplan-Mier survival analysis was made by using SPSS10.0 software. Results: There were 14 patients with non-Hodgkin lymphoma and 1 with Hodgkin disease enrolled. Male:female=11:4. Median age was 40 (30–64). At least 6 cycles of induction chemotherapy were given before transplantation. There were 3 patients in progression disease, 1 in stable disease, and 11 in partial remission before transplantation. Three patients received total lymph node irradiation (TLI). Seven patients received TBI(200cGY)+involved field irradiation therapy(IFIT). Five were treated with IFIT. All patients acheaved complete response(including 1 CRu) after radiotherapy. Three patients relapsed. One patient treated with TBI+IFIT relapsed at 6 months later. Two patients treated with IFIT relapsed at 8 and 36 months later respectively. The mean disease-free survival and overall survival were 10.84(SD1.37,95%CI) years and 11.89(SD1.35,95%CI) years respectively. The estimatrd 10-year disease-free survival and Overall survival were both 73%. One patient developed AML at 86 month. Grade III–IV hematologic toxicity was seen in 2 patients. Conclusions: Post ASCT radiotherapy is safe and tolerated. Relaps rate is low. Patients who received TLI or TBI+IFIT seem to have better outcome than that received IFIT only.

Chronic Graft Versus Host Disease and Pretransplant Disease Status Predict Outcomes in Patients with Hematologic Malignancies Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5090-5090
Author(s):  
Megha A. Shah ◽  
Mounzer Agha ◽  
Markus Mapara ◽  
Kate Lenhart ◽  
Anastasios Raptis
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Chronic Gvhd ◽  
Disease Free Survival ◽  
Disease Status ◽  
Hematologic Malignancies ◽  
Free Survival ◽  
Effective Treatment Modality ◽  
Disease Free ◽  
Reduced Intensity

Abstract Reduced intensity stem cell transplantation (SCT) is an effective treatment modality for patients with hematologic malignancies who are not candidates for conventional myeloablative SCT. We conducted a retrospective review of all patients with hematologic malignancies receiving a reduced intensity allogeneic SCT from July 2002 to July 2007. Data pertaining to patient demographics, engraftment, disease status pre and post transplant, graft versus host disease (GVHD), and HLA matching was analyzed to identify factors significantly affecting the clinical outcome. Seventy three patients, with a median age of 55 (range of 19–70) and with the diagnoses of ALL (n=8), AML (n=30), CLL (n=3), CML (n=1), Hodgkin’s (n=7), non-Hodgkin’s (n=7), MDS (n=11), and MM (n=6) underwent a reduced intensity SCT using a fludarabine based conditioning regimen. Thirty nine (53%) received unrelated donor grafts and 34 (47%) received sibling donor grafts. Fifty six patients (77%) received fully matched grafts whereas 17 patients (23%) had an antigen or allele mismatch. Acute GVHD grade II-IV was observed in 27 of the 73 patients and chronic GVHD was seen in 18 of the 48 patients who could be evaluated. Seventeen patients developed transplant related fatal complications and 30 patients died from disease progression or relapse. Median time to neutrophil recovery was 15 days (range of 9–41 days) and median time to platelet recovery was 18 days (range of 9–42 days). Graft failure was observed in 6 of the 73 patients. Median overall survival and disease free survival for all patients was 7.7 and 6.6 months respectively. Median overall survival for patients with persistent disease or in remission at the time of the SCT was 5.6 and 21.8 months (p= 0.01) while that for disease free survival was 5.7 and 8.4 months (p=0.06). Median overall survival with and without chronic GVHD was 25.6 and 9.4 months (p <0.0001) while median disease free survival was 18.2 and 6.0 months (p< 0.0001). Patients with limited chronic GVHD have not yet reached median overall survival while the median disease free survival was 18.4 months. Those with no or extensive chronic GVHD had medians of 9.4 and 9.2 months for overall survival and 6.0 and 9.2 months for disease free survival (p= 0.004 and p=0.02). The source of the stem cells as well as the administration of allele or single antigen mismatch grafts did not affect the outcome. Reduced intensity SCT is an effective treatment modality in patients with hematologic malignancies, though it is most effective in patients who are in remission at the time of transplant and should be offered in this setting. Patients with limited chronic GVHD had a better outcome suggesting the presence of potent anti-tumor activity of the donor immune competent cells without the detrimental effects in clinical outcome caused by extensive chronic GVHD.

Surgery of colorectal metastasis in the Optimox 1 study. A GERCOR Study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3522-3522 ◽  
Author(s):  
N. Perez-Staub ◽  
G. Lledo ◽  
F. Paye ◽  
B. Gayet ◽  
M. Flesch ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Response Rate ◽  
Disease Free Survival ◽  
Complete Response ◽  
Additional Benefit ◽  
Curative Intent ◽  
Free Survival ◽  
Before And After ◽  
Unresectable Metastasis ◽  
Disease Free

3522 Background: Surgery of metastasis can cure arround 20% of metastatic colorectal cancer (MCRC) patients. The Optimox 1 study achieved a response rate over 50% with FOLFOX therapy in patients (pts) with initially unresectable metastasis which allowed to perform surgery in a significant number of pts (JCO 2006). We report here the results in pts who underwent surgery of metastasis (met). Methods: From jan 2000 to june 2002, 620 previously untreated patients with unresectable metastasis were randomized between FOLFOX4 every two weeks until progression (arm A), or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles and reintroduction of FOLFOX7 (arm B). 101 pts were resected with a curative intent, 57 in arm A and 45 in arm B. Results: Patients characteristics were (arm A/B %): metachronous metastasis 77/51, liver met 82/91, lung met 16/11, other met 7/4, PAL < 3 ULN: 98/97, normal LDH: 52/51. 8% of pts achieved a complete response, 72% a partial response, 16% a stable disease. 89 pts had a single resection, 12 had a two-stage surgery. One patient died in arm B. Eleven pts who relapsed had a second surgery. Resection was radical (R0) for 71 pts (43 in arm A and 28 in arm B), 15 were R1 (margin invasion) and 15 were R2. R0/R1 patients had a median overall survival (OS) of 51 mo in arm A and 38 mo in arm B. Median disease-free survival (DFS) since surgery was 12 mo in arm A and 9 mo in arm B, with no statistical difference. 32% of R0/R1 pts were alive with no progression at 3 years in arm A and 20% in arm B. Median time from randomization to surgery was 8 mo. No difference was found between patients resected before 8 mo (n = 50) and after (n = 37) in OS (39 vs 45 mo, p = .67) nor in DFS (11.6 vs 9.5 mo, p = .24). Neither in pts resected before and after 6 mo in OS (p = .77) and DFS (p = .44). Conclusions: FOLFOX treatment allowed 14 % of unresectable patients to be rescued by surgery. There was no additional benefit to perform surgery after 6 months of therapy compared to early surgery. [Table: see text]

Long-Term Results of RTOG Trial 8911 (USA Intergroup 113): A Random Assignment Trial Comparison of Chemotherapy Followed by Surgery Compared With Surgery Alone for Esophageal Cancer

2007 ◽  
Vol 25 (24) ◽  
pp. 3719-3725 ◽  
Author(s):  
David P. Kelsen ◽  
Katryn A. Winter ◽  
Leonard L. Gunderson ◽  
Joanne Mortimer ◽  
Norman C. Estes ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Preoperative Chemotherapy ◽  
Disease Free Survival ◽  
R0 Resection ◽  
Free Survival ◽  
R1 Resection ◽  
The Relationship ◽  
Disease Free

Purpose We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. Patients and Methods The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Results Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. Conclusion For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.

scholarly journals Positive Programmed Cell Death-Ligand 1 Expression Predicts Poor Treatment Outcomes in Esophageal Squamous Cell Carcinoma Patients Receiving Neoadjuvant Chemoradiotherapy

2019 ◽  
Vol 8 (11) ◽  
pp. 1864 ◽  
Author(s):  
Huang ◽  
Lu ◽  
Wang ◽  
Chen ◽  
Lo ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitor ◽  
Neoadjuvant Chemoradiotherapy ◽  
Disease Free Survival ◽  
Complete Response ◽  
Hazard Ratio ◽  
Free Survival ◽  
Disease Free

Background: Programmed cell death-ligand 1 (PD-L1) is present in a subgroup of cancer patients who may be favorable targets for immune checkpoint inhibitor therapies. However, the significance of the PD-L1 expression in esophageal squamous cell carcinoma (ESCC) patients receiving neoadjuvant chemoradiotherapy remains unclear. Methods: By means of PD-L1 immunohistochemistry 22C3 pharmDx assay, we evaluate the PD-L1 expression and its association with clinical outcome in 107 ESCC patients receiving neoadjuvant chemoradiotherapy. Results: Patients with positive PD-L1 expression have significantly lower pathological complete response rates (13% versus 32%; P = 0.036) than those with negative PD-L1 expression. Univariate survival analysis found that positive PD-L1 expression were correlated with poor overall survival (P = 0.004) and inferior disease-free survival (P < 0.001). In a multivariate analysis, positive PD-L1 expression was independently associated with the absence of a pathologically complete response (P = 0.044, hazard ratio: 3.542), worse overall survival (P = 0.006, hazard ratio: 2.017), and inferior disease-free survival (P < 0.001, hazard ratio: 2.516). Conclusions: For patients with ESCC receiving neoadjuvant chemoradiotherapy, positive PD-L1 expression independently predicts the poor chemoradiotherapy response and worse treatment outcome. Thus, our data suggests that PD-L1 may be an influential biomarker for prognostic classification and for immune checkpoint inhibitor therapies in ESCC patients receiving neoadjuvant chemoradiotherapy.

Association of mucin production and survival in colon cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 512-512 ◽  
Author(s):  
John Hogan ◽  
Georges Samaha ◽  
John Burke ◽  
David Waldron ◽  
Eoin Condon ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Univariate Analysis ◽  
Disease Free Survival ◽  
Free Survival ◽  
Mucin Production ◽  
Kaplan Meier ◽  
The Relationship ◽  
Disease Free

512 Background: Debate persists regarding the relationship between mucin production and cancer-related outcome following curative resection for colon cancer. Lack of consensus is due to (amongst other factors) discrepancies in definition, small cohort studies and the integration of both colon and rectal cancers. This study characterizes the relationship between mucin production and cancer-related outcome in an homogenous single-institute based cohort. Methods: A database spanning demographics, clinico-pathologic characteristics and prognostic factors was generated for all patients undergoing curative-intent colonic resection in the interval 2000 to 2010. Patients were categorized simply as mucin producing (i.e. MC) or non-mucin producing adenocarcinoma (NMC). Primary outcomes included overall survival (time to death from any cause) and disease free survival (time to loco-regional and systemic recurrence). Trends were established for MC and NMC using Kaplan-Meier estimates, plotted and compared using log-rank analysis. Findings significant on univariate analysis were incorporated into multivariate analysis. Cox proportional hazards model was employed to determine the associated hazard of both death and disease recurrence in each group. Statistical analysis was performed using R version 2.15. P < 0.05 was considered significant. Results: 77 mucinous carcinomas (MC) and 358 non mucinous carcinomas (NMC) were included. On univariate analysis, MC was associated with improved overall survival (OS) (P=0.007). Both N1 (HR 1.625, P=0.011) and N2 (HR 2.7, P<0.001) status were associated with adverse OS. On multivariate analysis, MC approached but did not reach statistical significance for improved OS (HR 0.543, P=0.061). A comparison of Kaplan-Meier estimates for overall survival in MC and NMC groups indicated that OS was significantly improved in the MC cohort (P=0.011). There was no difference in disease free survival (P=0.224). Systemic recurrence was greater in the NMC group (P=0.042). Conclusions: Mucin production in colonic adenocarcinoma appears associated with improved overall but not disease-free survival. In addition, the absence of mucin was associated with adverse systemic but not local recurrence.

The efficacy and feasibility of weekly 5-FU and cisplatin based radical concurrent chemoradiation therapy(CRT) in patients with esophageal cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 169-169
Author(s):  
Joon Won Jeong ◽  
Ji Hyun Yang ◽  
Sang Mi Ro ◽  
In-Ho Kim ◽  
Sang Young Roh
Keyword(s):  
Esophageal Cancer ◽  
Median Overall Survival ◽  
Disease Free Survival ◽  
Squamous Carcinoma ◽  
Complete Response ◽  
Definitive Treatment ◽  
Free Survival ◽  
Promising Treatment ◽  
Grade 3 ◽  
Disease Free

169 Background: Concurrent chemoradiotherapy(CCRT) has become a promising treatment for esophageal cancer. Mostly, however, 3 week or 4 week interval of conventional FP(5-fluorouracil plus cisplatin) regimen is adopted, which is usually associated with moderate to severe treatment-related toxicities. Studies about weekly regimen of FP CCRT are little known, thus we studied the efficaty, tolerability and toxicities of weekly FP CCRT regimen. Methods: From February 2010 to august 2015, Patients staging from I to III esophageal cancer(according to AJCC 7th edition) were enrolled, who were received radiation therapy with dose of from 50.4Gy to 60Gy(5 days/week) and 5-FU 1000mg/BSA with cisplatin 30mg/BSA weekly. Results: From February 2010 to august 2015, 50 patients: male/female 47/3, median age 71.5 (47-78), all of 50 patients was squamous carcinoma, well/moderately differentiated carcinoma 1/18. 45 patients completed CRT without dose reduction, 9 patients received less than 6 cycles of chemotherapy, 4 patients received less than 50.4Gy of radiotherapy. Major toxicities of grade 3 or less were as follows: neutropenia 52%, thrombocytopenia 21%, nausea & vomiting 10%, fatigue 10%, anemia 5%. Toxicities over grade 4 was seen only in 1 patient. 15 patients showed complete response. The median overall survival was 10.67 months(4-48). The median disease-free survival was 16.9 months. Conclusions: Weekly regimen of concurrent CRT with 5-FU and cisplatin resulted in less toxicities over grade 3. Although, this regimen still showed non-inferiority to previous conventional 4 week-interval FP CCRT regimens in terms of PFS and OS. In this study, 82% of our patients had completed CCRT without any interruption. Hence, our results suggest that CRT with weekly 5-FU and cisplatin as definitive treatment for esophageal cancer could be a tolerable regimen.

Change In Albumin Levels During Induction Predicts Survival Outcomes In Adult Acute Lymphoblastic Leukemia

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1403-1403
Author(s):  
Kimberly Komatsubara ◽  
Tamara J. Dunn ◽  
Daniel J Lee ◽  
Steven E. Coutre ◽  
Caroline Berube ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Lymphoblastic Leukemia ◽  
Disease Free Survival ◽  
Adult Patients ◽  
Free Survival ◽  
Significant Difference ◽  
Asparaginase Activity ◽  
Baseline Characteristics ◽  
Disease Free

Abstract Background Asparaginase is an important component of induction and consolidation chemotherapy for acute lymphoblastic leukemia (ALL). Effective asparagine depletion in adult patients with ALL results in a longer duration of overall survival and disease free survival. Variation in asparaginase activity is in part due to the formation of anti-asparaginase antibodies that inactivate asparaginase and result in inadequate asparagine depletion. In addition, the presence of anti-asparaginase antibodies influences dexamethasone pharmacokinetics by increasing dexamethasone clearance, which has been shown to correlate with a higher risk of relapse. Hypoalbuminemia is a recognized side effect of asparaginase, and has been studied as a measure of asparaginase inhibition of liver protein synthesis. The purpose of this retrospective study was to evaluate the effect of asparaginase activity during induction, using serum albumin as a surrogate marker, on overall outcomes. We hypothesized that patients with lower albumin levels, and thus increased asparaginase activity, would have improved survival. Methods A retrospective electronic chart review was performed on 108 adult patients with newly diagnosed ALL who underwent induction chemotherapy treatment with Cancer and Leukemia Group B (CALGB) 9511 protocol at Stanford Hospital and Clinics between 2004 and 2012. PEG-asparaginase (2000 units per m2, capped at 3750 units) administration on day 5 of induction was confirmed on the electronic medical administration record. Patients also received therapy per protocol including prednisone (60mg per m2 per day) from days 1 through 21, with the exception of patients >60 years old who received prednisone from days 1 through 7. The primary outcomes measured were median overall survival and disease free survival. Patients were divided based on percent change in albumin level at day 14 of induction, using 20% decrease from pre-treatment baseline as a cut-off. The log rank test was used to calculate differences in survival and the Cox proportional hazards model was used to calculate hazard ratios. Baseline characteristics between the two groups were compared using chi-square or t-test analysis. Results A total of 104 patients with newly diagnosed ALL were included in the final analysis (1 patient did not receive PEG-asparaginase and 3 were lost early to follow-up). Of these, 52% were male. The median age was 49 years, and 20% of patients were 60 or older. The majority had B cell ALL (88%). Cytogenetics were normal in 28% of patients; t(9;22) was observed in 28% and t(4;11) in 4%. The induction mortality was 9% and 88% achieved complete remission (CR). In the entire patient population, the median overall survival was 27.4 months, and the median disease free survival was 25.0 months. For the patients who achieved at least a 20% decrease in albumin at day 14 of induction (57 patients), there was a statistically significant difference in median overall survival compared to those who had less than a 20% decrease in albumin, with an overall survival duration of 47.4 months and 15.8 months, respectively (HR = 2.23, P = 0.007). The median duration of disease free survival in those who achieved at least a 20% decrease in albumin at day 14 was 39 months compared to 13 months in those with less than a 20% decrease (HR = 1.93, P = 0.039). There was no statistically significant difference in the rate of CR between the two groups (P = 0.503). There was also no statistically significant difference in the baseline characteristics (age, WBC at diagnosis, presence of Philadelphia chromosome, and proportion of patients who eventually underwent BMT) between the two groups. Conclusion This study found a correlation between a decrease in albumin levels during induction, which was used as a surrogate measure of asparaginase activity, and duration of overall survival and disease free survival. This suggests that lower albumin levels associated with higher asparaginase activity and adequate asparagine depletion are important predictors of outcomes. Further studies assessing the effect of optimal individualized dosing of asparaginase based on albumin levels and/or asparagine depletion might be helpful to improve outcomes of adult patients with ALL. Disclosures: No relevant conflicts of interest to declare.

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