Addition of ATRA to the Maintenance Protocol Did Not Improve Disease-Free Survival: Results of the Russian APL Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4374-4374
Author(s):  
Elena N. Parovichnikova ◽  
Valeri G. Savchenko ◽  
Valentin G. Isaev ◽  
Elena N. Shuravina ◽  
Irina A. Demidova ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Total Dose ◽  
Randomized Clinical Trial ◽  
Maintenance Treatment ◽  
Disease Free Survival ◽  
Final Analysis ◽  
Study Group ◽  
Free Survival ◽  
Multivariant Analysis ◽  
Disease Free

Abstract Russian Leukemia study group is presenting the final analysis of the APL-06.01. randomized clinical trial. The aim of the study was to identify the efficacy of ATRA substitution of each other chemotherapy course while the 2-yrs maintenance after three induction/ consolidation 7+3 with daunorubicin dose of 180 mg/m2 per course and ATRA for 30 days while the first induction. The patients were randomized for two types of maintenance - (I type) rotation of 5-days ARA-C (100 mg/m2 bid) combined with daunorubicin (45 mg/m2 for 2 days, till the total dose of 650 mg/m2) or 6-MP (50mg/m2 p.o.5 days) or CHP (800 mg/m2 i.v.1 day) or (II type) rotation of the same courses of chemotherapy with 5-days 45 mg/m2 ATRA course. The II type of maintenance treatment contained twice less chemotherapy. The intervals between courses were 4 weeks From July, 2001 till January, 2006 114 APL patients from 26 centers were enrolled in the study. In 95% of pts APL was confirmed by cytogenetics or PCR. 102 patients were included in the analysis. CR rate was 85%, ED rate -15%, 4-yrs OS -68,3%, DFS - 77,4%, CCR - 89,5%. Suvival analysis according to randomization did not demonstrate statistical differences, but showed a trend (p=0,06) towards better DFS and CCR in patients maintened with chemotherapy only: 85,2% and 94,3% (I type) and 77,7% and 85,6% (II type). In the multivariant analysis only one factor was defined as statistically significant - the number of the patients randomized by the participating centers. OS and DFS were much higher in the centers randomized 6 and more patients comparing with less than 6 patients: 82,9%and 90,7% vs 48,8% and 63%, respectively (0,003). 1. So we can suggest that maintenance with ATRA alternating with chemotherapy is less effective than chemotherapy only. Whether addition not substitution of ATRA to chemotherapy maintenance will change the results will be checked in the next study.2. The experince of the centers in APL treatment is a cruicial point for survival.

Randomized Clinical Trial of Adjuvant Mitomycin Plus Tegafur in Patients With Resected Stage III Gastric Cancer

1999 ◽  
Vol 17 (12) ◽  
pp. 3810-3815 ◽  
Author(s):  
Lluís Cirera ◽  
Anna Balil ◽  
Eduard Batiste-Alentorn ◽  
Ignasi Tusquets ◽  
Teresa Cardona ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Free Survival ◽  
Resected Stage ◽  
Disease Free

PURPOSE: The efficacy of adjuvant chemotherapy in gastric cancer is controversial. We conducted a phase III, randomized, multicentric clinical trial with the goal of assessing the efficacy of the combination of mitomycin plus tegafur in prolonging the disease-free survival and overall survival of patients with resected stage III gastric cancer. PATIENTS AND METHODS: Patients with resected stage III gastric adenocarcinoma were randomly assigned, using sealed envelopes, to receive either chemotherapy or no further treatment. Chemotherapy was started within 28 days after surgery according to the following schedule: mitomycin 20 mg/m2 intravenously (bolus) at day 1 of chemotherapy; 30 days later, oral tegafur at 400 mg bid daily for 3 months. Disease-free survival and overall survival were estimated using the Kaplan-Meier analysis and the Cox proportional hazards model. RESULTS: Between January 1988 and September 1994, 148 patients from 10 hospitals in Catalonia, Spain, were included in the study. The median follow-up period was 37 months. The tolerability of the treatment was excellent. The overall survival and disease-free survival were higher in the group of patients treated with chemotherapy (P = .04 for survival and P = .01 for disease-free survival in the log-rank test). The overall 5-year survival rate and the 5-year disease-free survival rate were, respectively, 56% and 51% in the treatment group and 36% and 31% in the control group. CONCLUSION: Our positive results are consistent with the results of recent studies; which conclude that there is a potential benefit from adjuvant chemotherapy in resected gastric cancer.

scholarly journals Immunohistochemical Analysis Revealed a Correlation between Musashi-2 and Cyclin-D1 Expression in Patients with Oral Squamous Cells Carcinoma

2019 ◽  
Vol 21 (1) ◽  
pp. 121
Author(s):  
Giuseppe Troiano ◽  
Vito Carlo Alberto Caponio ◽  
Gerardo Botti ◽  
Gabriella Aquino ◽  
Nunzia Simona Losito ◽  
...  
Keyword(s):  
Cyclin D1 ◽  
Mrna Expression ◽  
Rna Binding ◽  
Disease Free Survival ◽  
Immunohistochemical Analysis ◽  
Final Analysis ◽  
The Cancer Genome Atlas ◽  
Free Survival ◽  
Prognostic Features ◽  
Disease Free

Aim: Musashi 2 (MSI2), which is an RNA-binding protein, plays a fundamental role in the oncogenesis of several cancers. The aim of this study is to investigate the expression of MSI2 in Oral Squamous Cell Carcinoma (OSCC) and evaluate its correlation to clinic-pathological variables and prognosis. Materials and Methods: A bioinformatic analysis was performed on data downloaded from The Cancer Genome Atlas (TCGA) database. The MSI2 expression data were analysed for their correlation with clinic-pathological and prognostic features. In addition, an immmunohistochemical evaluation of MSI2 expression on 108 OSCC samples included in a tissue microarray and 13 healthy mucosae samples was performed. Results: 241 patients’ data from TCGA were included in the final analysis. No DNA mutations were detected for the MSI2 gene, but a hyper methylated condition of the gene emerged. MSI2 mRNA expression correlated with Grading (p = 0.009) and overall survival (p = 0.045), but not with disease free survival (p = 0.549). Males presented a higher MSI2 mRNA expression than females. The immunohistochemical evaluation revealed a weak expression of MSI2 in both OSCC samples and in healthy oral mucosae. In addition, MSI2 expression directly correlated with Cyclin-D1 expression (p = 0.022). However, no correlation has been detected with prognostic outcomes (overall and disease free survival). Conclusions: The role of MSI2 expression in OSCC seems to be not so closely correlated with prognosis, as in other human neoplasms. The correlation with Cyclin-D1 expression suggests an indirect role that MSI2 might have in the proliferation of OSCC cells, but further studies are needed to confirm such results.

Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient mismatch repair (ATOMIC, Alliance A021502).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15169-e15169 ◽  
Author(s):  
Frank A. Sinicrope ◽  
Fang-Shu Ou ◽  
Tyler Zemla ◽  
Andrew B. Nixon ◽  
Kabir Mody ◽  
...  
Keyword(s):  
Clinical Trial ◽  
T Cells ◽  
Randomized Trial ◽  
Mismatch Repair ◽  
Total Duration ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Stage Iii ◽  
Free Survival ◽  
Disease Free

e15169 Background: In metastatic colorectal cancer with deficient DNA mismatch repair (dMMR), anti-PD-1 antibody monotherapy produced high tumor response rates and extended progression-free survival compared to lack of benefit for cancers with proficient MMR. In an ongoing phase III randomized trial, we will determine if the addition of the anti-PD-L1 antibody, atezolizumab (Genentech), to adjuvant FOLFOX can improve patient disease-free survival (DFS) vs FOLFOX alone in patients with stage III colon cancers with dMMR. By blocking the PD-1/PD-L1 interaction, atezolizumab may activate T cells, thereby, restoring their ability to detect and attack tumor cells. Limited data suggest that FOLFOX may increase intratumoral cytotoxic CD8+ T cells that could serve as ‘immune priming'. Methods: Patients with curatively resected stage III colon carcinomas with evidence of dMMR are randomized to modified FOLFOX6 for 6 months (12 cycles) alone (control arm) or combined with atezolizumab (840 mg IV q2 wk) with continuation of the antibody as monotherapy for an additional 6 months (total duration of 12 months) [experimental arm]. Patients will be stratified by T, N stage and tumor sidedness. Local testing for MMR proteins is allowed. Atezolizumab must begin by/with cycle 2. One cycle of FOLFOX is allowed pre-registration. The targeted accrual goal of 700 patients and 165 disease-free survival (DFS) events will provide 90% power to detect an effect size expressed as hazard ratio of 0.6 for the primary endpoint of DFS at two-sided alpha of 0.05. Interim analyses are planned at 50% and 75% of events. Secondary endpoints include overall survival, treatment tolerability, and quality of life. Results: This study is being conducted by the Alliance for Clinical Trials in Oncology, was approved by NCI CTEP and activated in 09/2017. The study is actively accruing and, as of 02/11/2019, 152 patients are enrolled. We are actively exploring an international collaboration. Conclusions: This is a current clinical trial in progress. Clinical trial information: NCT02912559.

Association of postoperative serum carcinoembryonic antigen (CEA) with disease-free survival in patients with stage III colon cancer: ACHIEVE phase III randomized clinical trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4069-4069
Author(s):  
Masahito Kotaka ◽  
Dai Manaka ◽  
Tetsuya Eto ◽  
Junichi Hasegawa ◽  
Akinori Takagane ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
Carcinoembryonic Antigen ◽  
Cox Regression ◽  
Disease Free Survival ◽  
Free Survival ◽  
Cutoff Values ◽  
Serum Carcinoembryonic Antigen ◽  
Serum Cea ◽  
Disease Free

4069 Background: ACHIEVE, as part of the IDEA collaboration, was a multicenter trial randomizing patients with stage 3 resected colon cancer to either 3 versus 6 months of adjuvant FOLFOX/CAPOX. We previously reported that the hazard ratios (HRs) in disease-free survival (DFS) of 3 versus 6 months duration according to risk stage (low-risk [T1-3 and N1] or high-risk [T4 or N2]) and regimen (FOLFOX or CAPOX) as well as in overall population were consistent with those observed in the whole IDEA. This study aimed to clarify the significance of post-operative serum carcinoembryonic antigen (CEA) on DFS in stage 3 colon cancer. Methods: Eligibility included post-operative serum CEA value of ≤10 ng/ml at registration in the ACHIEVE trial, which enrolled 1313 patients between 2012 and 2014, out of whom 1291 pts were the modified ITT (mITT) population and used in this study. The cutoff values of CEA analyzed for prognostic analyses were the median value (1.8 ng/ml) in the mITT, the upper limit of normal (ULN) level (5.0 ng/ml), and the half of ULN (2.5 ng/ml). The association of post-operative CEA with DFS were measured by Cox regression analyses. Results: Of the 3 cutoff values, the ULN (5.0 ng/ml) was associated with DFS more strongly than the median (1.8 ng/ml) or half of ULN (2.5 ng/ml), with a HR of 1.75 (95%CI, 1.24-2.46) (Table). The 99 patients (7.7%) were identified as the CEA > ULN and 1192 (92.3%) as < ULN. In univariate analysis, regimen (CAPOX or FOLFOX), ECOG PS (0 or 1), T factor (T1-3 or T4), N factor (N1 or N2-3) and CEA ( < ULN or > ULN) were significantly associated with DFS. Multivariate Cox regression identified CEA > ULN as an independent poor risk factor (HR = 1.45; 95%CI, 1.03-2.05). Shorter DFS in patients with CEA > ULN than in those with CEA < ULN was consistently observed in each subgroup of baseline factors, including treatment duration, regimen, age, gender, PS, T-stage, N-stage, no of lymph nodes examined, and tumor location; no interaction was observed between CEA and these factors. Conclusions: Post-operative serum CEA is also a strong prognostic factor for DFS in stage 3 colon cancer. Clinical trial information: 000008543 . [Table: see text]

The Safety and Therapeutic Effect Analysis of Intraoperative Intraperitoneal Chemotherapy with Lobaplatin for Hepato-Biliary-Pancreatic Cancer

2020 ◽  
Author(s):  
Gang Chen ◽  
Hao Chen ◽  
Qifan Zhang ◽  
Siyun Zhang ◽  
Huanyu Li ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Intraperitoneal Chemotherapy ◽  
Disease Free Survival ◽  
Control Group ◽  
Study Group ◽  
Free Survival ◽  
Significant Difference ◽  
Liver And Kidney ◽  
Intraperitoneal Perfusion ◽  
Disease Free

Abstract Background To examine the safeness and efficacy of intraoperative intraperitoneal perfusion chemotherapy with lobaplatin on hepato-biliary-pancreatic cancer. Methods Clinical data were retrospectively collected from a total of 66 patients with HBP cancer undertaken surgeries. They were divided into two groups: the study (lobaplatin) group (33 patients) and the control group (33 patients). The disease-free survival rate, postoperative complications, and chemotherapy side effects (bone marrow, liver, and kidney toxicity) were analyzed to examine the safeness and efficacy of intraoperative intraperitoneal chemotherapy with lobaplatin. Results In the study group, two patients had a postoperative subphrenic infection and increased peritoneal effusion, one patient had postoperative leukopenia and thrombocytopenia, while the control group had postoperative abnormal coagulation function in 1 patient, and gastrointestinal bleeding in 1 patient, no significant difference in postoperative complication was observed between the two groups. There was no significant difference in the liver and kidney function between the two groups after surgery (p > 0.05). A total of 26 patients in the two groups had recurrence or metastasis within one year after surgery, including eight patients in the study group and 18 patients in the control group. The recurrence rate of hepatocellular cancer in the lobaplatin group and control was 21.14% and 60%, respectively (P = 0.012 < 0.05). But there was no significant difference in the disease-free survival function analysis (P = 0.127 > 0.05). Conclusions Intraperitoneal perfusion chemotherapy with lobaplatin is a safe and effective treatment in the process of radical resection of hepato-biliary-pancreatic tumors, which has therapeutic potential in reducing postoperative tumor recurrence and metastasis.

BiovaxID™ Vaccine Therapy of Follicular Lymphoma in First Remission: Long-Term Follow-Up of a Phase II Trial and Status of a Controlled, Randomized Phase III Trial.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2441-2441 ◽  
Author(s):  
Carlos Santos ◽  
Lee Stern ◽  
Laura Katz ◽  
Thelma Watson ◽  
Gause Barry
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Disease Free Survival ◽  
T Cell Response ◽  
Phase Iii ◽  
Patient Specific ◽  
Free Survival ◽  
The Impact ◽  
Disease Free

Abstract Malignant B-cells in Follicular Non-Hodgkin’s Lymphoma expresses a clonal idiotype immunoglobulin which can serve as the basis for a patient-specific anti-idiotype vaccine. In a previous single-arm Phase II study by Bendandi, et al (Nature Med5:1171–1177, 1999), we evaluated the ability of tumor-specific idiotype (Id) conjugated to keyhole limpet hemocyanin (KLH) administered concurrently with granulocyte-monocyte colony-stimulating factor (GM-CSF) adjuvant to induce complete remissions and molecular remissions in treated patients. The vaccine formulation induced a tumor-specific cytotoxic CD8+ and CD4+ T-cell response in patients in first complete remission after standard chemotherapy, as well as achieved molecular remissions in 8 of 11 of these patients. Data available at the time of this abstract for the 20-patient cohort, indicates a median follow-up of 9.167 years. 9 patients (45 %) remain in continuous first CR at their most recent follow-up (either in 2004 or 2005), and overall survival is 95%. The data further indicates the median disease free survival for the cohort is 96.5 months (8.04 years). To date there have been no additional reported mortalities in this cohort. As of August 2005, we report the progress of the Phase III clinical trial for this vaccine, opened in January 2000 by the NCI to evaluate the impact of this hybridoma-based Id vaccine on disease-free survival in a group of up to 375 previously untreated patients who have attained a CR or CRu from PACE [Prednisone, Doxorubicin, Cyclophosphamide, and Etoposide (ProMACE without methotrexate)] chemotherapy, and who are randomized to receive either vaccine or control. To date, 187 patients have been accrued onto the study. Of those patients, 145 (77.5%) achieved a CR or Cru and are being followed in this ongoing clinical trial.

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