Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: Final overall survival analysis of phase II study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 726-726
Author(s):  
Lucjan Wyrwicz ◽  
Dobromila Tyc-Szczepaniak ◽  
Magdalena Mydlowska ◽  
Lucyna Pietrzak ◽  
Andrzej Rutkowski ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Overall Survival ◽  
Treatment Failure ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iv ◽  
Chemotherapy Response ◽  
Short Course ◽  
Pelvic Symptoms

726 Background: A palliative surgery and chemotherapy is the standard of care in stage IV rectal cancer patients with pelvic symptoms. Recently we published primary results of the single-arm phase II study on combination of short-course radiation (5x5 Gy) with an oxaliplatin-based chemotherapy started after one-week rest (NCT01157806). The study met its primary end-point with only 17.5% (95% CI 13% to 22%) of patients (pts) who needed stoma throughout the observation and 67% (95% CI 58% to 76%) of pts having significant resolution of pelvic symptoms. Here we provide the long-term follow up data after median 60 months of observation. Methods: 40 consecutive patients with symptomatic rectal cancer with unresectable distant metastases were enrolled from September 2009 to February 2011. The time of treatment failure on chemotherapy (TTF3) was measured from the start of radiation to disease progression on fluoropiridine, oxaliplatin and irinotecan. All eligible patients were assessed for KRAS/NRAS status. Due to limitations in access to targeted agents none of patients were treated with anti-angiogenic agents and anti-EGFR treatment was restricted to third line. Results: Total 40 pts were assessed for pelvic symptoms, chemotherapy response and overall survival. In the group of patients with survival reaching over 2 years we have not observed any additional local complications which were treated surgically. The patients with total symptoms’ resolution after one month had significantly longer time-to-treatment failure (TTF3) than non-responders (median 22.5 vs 5 months, p < 0.05), while patients with minor local response had intermediate TTF3. The subgroup of patients who experienced clinical complete response of rectal tumor had a median TTF3 and overall survival reaching median 40 months. Conclusions: In the palliative setting short-course radiotherapy and early chemotherapy allowed for acceptable and durable local control. Metastatic rectal cancer patients with early symptomatic response of primary tumor had significantly better prognosis. Clinical trial information: NCT01157806.

scholarly journals EP-1424: Palliative short-course radiotherapy in rectal cancer: a phase II study

2016 ◽  
Vol 119 ◽  
pp. S662-S663
Author(s):  
V. Picardi ◽  
F. Deodato ◽  
G. Macchia ◽  
A. Guido ◽  
L. Giaccherini ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Short Course ◽  
Short Course Radiotherapy

A phase II study to establish a referential arm for treatment of gastric cancer patients with intraperitoneal micrometastases

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15002-15002
Author(s):  
Y. Kodera ◽  
S. Ito ◽  
Y. Mochizuki ◽  
K. Kondo ◽  
N. Suzuki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Treatment Failure ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Cytologic Examination ◽  
Time To Treatment ◽  
Time To Treatment Failure ◽  
Gastric Cancer Patients

15002 Background: Gastric cancer patients with free cancer cells in the peritoneal cavity as detected by cytologic examination of the peritoneal washes (CY1) are known to have dismal prognosis. In vivo studies by the authors suggest prognostic impact of early postoperative treatment with S-1 (Nakanishi H, et al. Cancer Sci 2003;94:112–8) . No standard treatment for this population has been proposed to date. Methods: A phase II study was conducted to evaluate the efficacy of S-1, a new oral fluoropyrimidine, given postoperatively to patients with CY1 disease. Eligibility criteria included histologically confirmed adenocarcinoma of the stomach without distant metastasis (peritoneal seeding allowed if completely resected), curatively resected with negative margins, <80 years of age with adequate organ functions and preoperative PS of 0∼2, and written informed consent. The primary endpoint was 2-year survival rate and secondary endpoints were time to treatment failure and safety. By referring to the historical control (2-year survival rate: 13.3%, 90% CI 3.1∼23.5%), the target 2- year survival rate was set at 36 % with estimated 90% CI>23.5%, and the sample size was calculated as 50. Results: Forty eight patients were accrued before the study was closed, and one patients was found to be ineligible (negative for the cytologic examination). Of 47 patients, 32 were men. Median age was 66 years (range: 39∼79 years). Serosal invasion was confirmed in 44 patients (94%) and node metastasis in 42 (89%). Seven patients had macroscopic but resectable peritoneal deposits. D2 dissection was encouraged and performed in 33 patients (70%). To date, median survival time was 21.7 months with 2-year survival rate of 43.5%. One patient died of ischemic heart disease 5 days after the initiation of treatment, and treatment for 7 other patients was discontinued due to toxicity. Time to treatment failure was 9.8 months and progression-free survival was 12.9 months. The most frequent >G3 toxicity was neutropenia (n=6), followed by anorexia/nausea (n=4). Conclusions: Although further period of observation is required, postoperative S-1 is likely to overwhelm the survival data obtained in the pre-S-1 era. Toxicity was manageable and 80% of the patients tolerated the treatment. No significant financial relationships to disclose.

A Prospective, Multicenter Phase II Study Of Continuous Infusion Of FLAG For Patients Older Than 60 Years With Resistant Acute Myeloid Leukemia: A Comparison With Intensive Younger patients’ Trial

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3968-3968
Author(s):  
Hawk Kim ◽  
Je-Hwan Lee ◽  
Young-Don Joo ◽  
Sung-Hwa Bae ◽  
Jung-Hee Lee ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Elderly Patients ◽  
Treatment Failure ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Myeloid Leukemia ◽  
Phase Ii Study ◽  
Younger Patients ◽  
Acute Myeloid

Abstract Relapsed/refractory acute myeloid leukemia (R/R AML) is hard to treat especially in elderly patients. We previously assessed continuous infusion (CI) of fludarabine and cytarabine plus idarubicin (CI-FLAG2) for patients under 65-years old with R/R AML. Also we started prospective phase II study of attenuated version of CI-FLAG2 for elderly patients (C-FLAG). R/R AML in elderly (¡Ã60 years old) patients were eligible. Induction chemotherapy consisted fludarabine and cytarabine (ARAC) as a 24-hr CI without idarubicin. Total 38 and 68 patients were enrolled in CI-FLAG1 and CI-FLAG2, respectively. There were no differences in terms of patients’ characteristics except for median age (p<0.001), HCT prior to salvage (p=0.002), WBC>20K/uL at salvage (p=0.004) and PB blast>40% at salvage, all which factors were unfavorable in C-FLAG. When comparing outcomes between CI-FLAG2 and C-FLAG, there were no difference in terms of CR rate (p=0.572) and objective response rate (ORR; p=0.899). Treatment failure patterns were also similar between C-FLAG and CI-FLAG2 (p=0.742). The most common treatment failure was resistant (66.7%) in C-FLAG. There were more frequent HCT in CI-FLAG2 (p<0.001) and consolidation chemotherapy in C-FALG (p=0.001). Poor predictors on ORR in C-FLAG were PB WBC>20K/uL at salvage (p=0.024) and PB blast >0% on early evaluation (p=0.013) by multivariate analysis. The overall survival of patients who achieve CR/CRp/CRi showed significantly prolonged survival compared with patients who did not in C-CLAG (p<0.001; Figure 1A). The median overall survivals were similar between CI-FLAG2 and C-FALG (p=0.427; Figure 1B).Figure 1Overall survivalFigure 1. Overall survival Attenuated salvage regimen C-FALG in elderly patients was as effective as more intensive younger patients’ regimen CI-FALG2 in terms of response and survival although elderly patients had more unfavorable clinical characteristics. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Short-course preoperative radiotherapy combined with chemotherapy, delayed surgery and local hyperthermia for rectal cancer: a phase II study

2017 ◽  
Vol 33 (4) ◽  
pp. 465-470 ◽  
Author(s):  
A. O. Rasulov ◽  
S. S. Gordeyev ◽  
Yu. A. Barsukov ◽  
S. I. Tkachev ◽  
A. G. Malikhov ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase Ii ◽  
Preoperative Radiotherapy ◽  
Phase Ii Study ◽  
Local Hyperthermia ◽  
Delayed Surgery ◽  
Short Course
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