Phase II Evaluation of Preoperative Chemoradiation and Postoperative Adjuvant Chemotherapy for Squamous Cell and Adenocarcinoma of the Esophagus

2000 ◽  
Vol 18 (4) ◽  
pp. 868-868 ◽  
Author(s):  
Elisabeth I. Heath ◽  
Barbara A. Burtness ◽  
Richard F. Heitmiller ◽  
Ronald Salem ◽  
Lawrence Kleinberg ◽  
...  
Keyword(s):  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Median Survival ◽  
Phase Ii ◽  
Treatment Plan ◽  
Pathologic Complete Response ◽  
Tumor Resection ◽  
Distant Metastases ◽  
Preoperative Chemoradiation ◽  
Preoperative Treatment

PURPOSE: This phase II trial evaluated continuous-infusion cisplatin and fluorouracil (5-FU) with radiotherapy followed by esophagectomy. The objectives of this trial were to determine the complete pathologic response rate, survival rate, toxicity, pattern of failure, and feasibility of administering adjuvant chemotherapy in patients with resectable cancer of the esophagus treated with preoperative chemoradiation. PATIENTS AND METHODS: Patients were staged using computed tomography, endoscopic ultrasound, and laparoscopy. The preoperative treatment plan consisted of continuous intravenous infusion of cisplatin and 5-FU and a total dose of 44 Gy of radiation. Esophagogastrectomy was planned for approximately 4 weeks after the completion of chemoradiotherapy. Paclitaxel and cisplatin were administered as postoperative adjuvant therapy. RESULTS: Forty-two patients were enrolled onto the trial. Of the 39 patients who proceeded to surgery, 29 responded to preoperative treatment: 11 achieved pathologic complete response (CR) and 18 achieved a lower posttreatment stage. Five patients had no change in stage, whereas eight had progressive disease (four with distant metastases and four with increases in the T and N stages). At a median follow-up of 30.2 months, the median survival time has not been reached and the 2-year survival rate is 62%. The median survival of pathologic complete responders has not been reached, whereas the 2-year survival rate of this group is 91% compared with 51% in patients with complete tumor resection with residual tumor (P = .03). CONCLUSION: An excellent survival rate, comparable to that of our prior preoperative trial, was achieved with lower doses of preoperative cisplatin and 5-FU concurrent with radiotherapy.

Adjuvant chemotherapy of S-1 versus S-1 plus metformin for resected pancreatic cancer: A multicenter and randomized phase II trial.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. TPS474-TPS474
Author(s):  
Masato Narita ◽  
Masayuki Furukawa ◽  
Ichiro Sakamoto ◽  
Yutaka Itoh ◽  
Hiroshi Nakano ◽  
...  
Keyword(s):  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Residual Tumor ◽  
Ductal Adenocarcinoma ◽  
Rank Test ◽  
Control Group ◽  
Study Group ◽  
Preoperative Treatment ◽  
Randomized Phase Ii

TPS474 Background: Adjuvant chemotherapy with S-1 in patients with resected pancreatic ductal adenocarcinoma (PDAC) improved the 5-year survival rate to 44.1% and therefore has been a standard of care in Japan. Recent epidemiologic data has revealed possibility of metformin (a drug for type II diabetes) improving the prognosis of PDAC. In this context, we compare the efficacy and safety of S-1 plus metformin with S-1 alone as adjuvant chemotherapy in patients with resected PDAC. Methods: This multicenter-randomized-phase II study is conducted at 29 institutions in Japan (Registry Number; UMIN000020681). Key eligibility criteria are age 20 years or more with good performance status; histologically proven PDAC of stage I-II without macroscopic residual tumor. Patients receiving preoperative treatment for PDAC and previously treated with DPP-4 inhibitor, GLP-1, and metformin are excluded. After giving written consent to the study, patients are randomly assigned either study group (S-1 plus metformin) or control group (S-1 alone), balancing residual tumor status, nodal status, and institutions. S-1 is given orally for 2 weeks in a 3-week cycle. Cycles are lasted for 6 months. In the study group, metformin is administrated together with S-1 for 2 years. The treatment would be discontinued when the patient has either recurrence or unacceptable toxicity. The primary endpoint is 2-year OS, and the secondary endpoints are relapse-free survival and incidence rate of adverse events. Sample size was calculated based on the data in previous trials, with an expected 2-year survival rate in the control group of 65%. An improvement in 2-year-survival rate from 65% in the control group to 78% in the study group, yielding a hazard ratio of 0.58, is considered clinically relevant in this population. A total of 73 events in each group were required for a power of 80% at a two-sided alpha 20% to detect a difference in OS using an unstratified log-rank test. A total of 160 patients (80 per group) were estimated to achieve the specified number of events in the scheduled follow-up. Duration of this study would be 5 years and it has been started from January 2018. Until September 2018, 17 patients have been enrolled. Clinical trial information: UMIN000020681.

Gemcitabine, oxaliplatin and weekly high-dose 5-FU as a 24-hr-infusion in chemonaive patients with advanced or metastatic carcinoma of the gallbladder: Preliminary results of a multicenter phase II-study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4129-4129 ◽  
Author(s):  
A. D. Wagner ◽  
P. Buechner-Steudel ◽  
H. Schmalenberg ◽  
M. Moehler ◽  
O. Kuss ◽  
...  
Keyword(s):  
Survival Rate ◽  
Median Survival ◽  
Phase Ii ◽  
Tumor Response ◽  
Phase Ii Study ◽  
Metastatic Carcinoma ◽  
Phase Iii ◽  
Carcinoma Of The Gallbladder ◽  
One Year ◽  
The One

4129 Background: Combinations of gemcitabine (GEM)/5-FU, GEM/oxaliplatin (LOHP) or 5-FU/LOHP work synergistically in pancreatic and/or colorectal malignancies, and have non-overlapping safety profiles. This phase II-study was designed to evaluate the efficacy and safety of the triple combination GEM/LOHP/5-FU in patients (pts) with advanced or metastatic carcinoma of the gallbladder. Methods: One-stage, multicentre phase II study. Eligibility criteria: chemonaive pts with histologically proven advanced, recurrent or metastatic gallbladder carcinoma (ECOG 0–1; expected survival >3 months; measurable disease; adequate renal, hepatic and bone marrow function). According to the results of our previous phase I-study (Proc ASCO 2003, # 1298), pts were treated with GEM 900mg/m2 as a 30-min infusion, followed by LOHP 65 mg/m2 (2-hr infusion) after a 30 min rest and 5-FU 1500 mg/m2 (24-hr-infusion) on d 1, 8, every 3 weeks. Planned sample size: 35 response evaluable patients. The primary endpoint was tumor response, secondary endpoints were toxicity, median survival, the one-year-survival rate, clinical benefit and quality of life. Results: At time of abstract submission, median follow-up of 35 enrolled pts is 9.8 months. Pt. characteristics: m/f: 11/24, median age 61 (range 42–81), ECOG 0/1: 24/11 (69/31%) pts, locally advanced/metastatic disease 1/32 (3/91%) pts. Analysis of tumor response is still pending. Grade III/IV (NCI-CTC) toxicities occurred in 36/3% of 191 cycles and were: leucopenia 3/1%, neutropenia 4/1%, thrombocytopenia 4/1%, anemia 2/0%, nausea 1/0%, sensory neuropathy 4/0%, asthenia 1/0%, elevated bilirubin 2/0%, AP 4/0%, or elevated SGOT/SGPT 1/0%, edema 1/0%, infection 1/0%, dyspnoe 1/1%. Median survival of all pts is 9.9 months (95% CI: 7.5–11.5), the one-year-survival-rate is 30 % (95% CI: 16–47). Conclusions: GEM/LOHP/5-FU combination therapy is tolerated well in patients with gallbladder cancer. The promising survival data has to be confirmed in a phase III study. (Supported by grants from Eli Lilly and Company, Indianapolis, IN, USA and Sanofi-Synthelabo, Paris, France). [Table: see text]

Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4519-4519 ◽  
Author(s):  
B. A. Burtness ◽  
M. Powell ◽  
J. Berlin ◽  
D. Liles ◽  
A. Chapman ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Median Survival ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Advanced Pancreatic Cancer ◽  
Growth Factor Receptor ◽  
Distant Metastases ◽  
Median Number ◽  
Number Of Cycles ◽  
Ecog Ps

4519 Background: Gemcitabine (G) is standard for metastatic pancreatic cancer (PC), with median survivals of 6 months (m). Second cytotoxic or biologic agents do not substantially advance survival. EGFR is expressed on PC and a phase II trial of G plus cetuximab (C) resulted in favorable 1 year survival. A phase II trial of irinotecan/docetaxel (I/D) chemotherapy reported a median survival for metastatic patients (pts) of 9 m. We conducted this randomized phase II trial to confirm the activity of this non-G regimen, and determine whether combining it with C was feasible and active. The primary endpoint was response. Methods: Pts required histologic confirmation of adenocarcinoma of the pancreas, evidence of distant metastases, ECOG PS 0–1, normal bilirubin, written informed consent, and were randomly assigned to Arm A (N=47) or B (N=45). Imaging with CT or MR within 4 weeks (wk) was used for tumor measurement. Dexamethasone was given 12 hours (h), 1 h before and 12 h after chemotherapy. Pts on Arm A received D 35 mg/m2 over 1 h and I 35 mg/m2 over 30 minutes weekly x 4 in a 6 wk cycle. Pts on Arm B received the same therapy, but C (loading dose 400 mg/m2 wk 1, 250 mg/m2 weekly thereafter) was given before D. Pts not receiving therapeutic anticoagulation received enoxaparin 40 mg per day. Pts were restaged (RECIST) after 2 cycles. Results: Median age Arm A: 59.9, Arm B: 60.2 years. Arm A 55% male, 32% PS 0, 97% EGFR immuno+. Arm B 84% male, 42% PS 0, 97% EGFR +. Median number of cycles for each arm 2 (1 -10). >4 cycles were delivered to 10.5% of pts Arm A, 20.9% Arm B. Grade ¾ neutropenia 26% Arm A, 33% Arm B. Grade 3 nausea 28% Arm A, 18% Arm B; Grade ¾ diarrhea 33% Arm A, 44.4% Arm B. 1 treatment-related death per arm. Median overall survival (OS), with 70.2% of pts known to have died, 6.5m [(95% CI (4.8, 8.6)] in Arm A. With 86.7% of pts known to have died in Arm B, OS 7.4 m [95% CI (4.4, 10.7)]. Response/progression data will be available at time of presentation. Conclusions: Weekly I/D ± C is associated with high rates of grade ¾ neutropenia/diarrhea. Median survival is 6.5m for I/D and 7.4m for I/D/C. Non-G containing therapy is active in metastatic PC. [Table: see text]

Preoperative chemoradiation with S-1 plus oxaliplatin in patients with locally advanced rectal cancer: Results of a phase II study and the role of apparent diffusion coefficient (ADC) by diffusion-weighted magnetic resonance imaging (DW MRI) for prediction of pathologic responses.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 629-629
Author(s):  
E. M. Lee ◽  
J. L. Hong ◽  
J. L. Lee ◽  
S. Y. Kim ◽  
Y. S. Park ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase I ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Preoperative Chemoradiation ◽  
Curative Surgery

629 Background: We conducted a phase II study of preoperative chemoradiation (CRT) with S-1, a novel oral fluoropyrimidine, plus oxaliplatin in patients (pts) with locally advanced rectal cancer. Tumor ADCs were measured by DW-MRI and were evaluated as a predictive marker for pathologic responses. Methods: Radiotherapy was delivered to a total 50.4 Gy. The recommended doses were determined by a previous phase I study; oxaliplatin 50 mg/m2/week on D1, 8, 22 and 29, and S-1 80 mg/m2/day on D1-14 and D22-35. Total mesorectal excision was performed within 6 ± 2 weeks. Primary endpoint was pathologic complete response (pCR) rate. The value of tumor ADCs by DW-MRI was measured before and after CRT, and was correlated with pathologic responses after surgery. Results: A total of 38 patients were enrolled; 22 (57.9%) were men and the median age was 54 years (range, 28-67). Of 35 patients who underwent curative surgery, 28 patients underwent sphincter-saving operations. There was no grade 4 toxicity, and grade 3 toxicities included leukopenia (2.7%), neutropenia (2.7%), anorexia (2.7%), nausea (2.7%) and diarrhea (8.8%). The pCR rate was 25.7% (8/35, 95% CI [10.9-42.1]) and additional 10 patients (28.6%) showed near total regressions of tumor. Tumor ADCs by DW-MRI were calculated in 38 patients (including phase I part). The post-CRT ADC and the ADC changes (ΔADC) were significantly correlated with pCR rate (post-CRT ADC: 1.52±0.46 vs. 1.07±0.58, p=0.037, ΔADC: 44.5% vs. -7.6%, p=0.026). Conclusions: Preoperative CRT with S-1 plus oxaliplatin showed promising results in pathologic responses and favorable toxicities profiles. Tumor ADC by DW-MRI seems to be a useful method for predicting responses. No significant financial relationships to disclose.

Use of perioperative therapy in gastric cancer: A retrospective comparison of ECF and chemoradiation.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 112-112
Author(s):  
V. Siripurapu ◽  
J. C. Watson ◽  
J. P. Hoffman
Keyword(s):  
Gastric Cancer ◽  
Median Survival ◽  
Locally Advanced ◽  
Survival Rates ◽  
Pathologic Complete Response ◽  
Preoperative Treatment ◽  
Perioperative Therapy ◽  
Significant Group ◽  
Group 2 ◽  
Group 1

112 Background: Gastric Cancer (GC) remains a major cause of cancer related morbidity and mortality in Western Countries with five year survival rates between 30%-40%. Preoperative therapy has been championed by groups extrapolating data from the Intergroup 0116 and the MAGIC trials, with a view to enhancing completion of therapy and improving survival in locally advanced tumors. Methods: Patients with preoperative treatment of GC were reviewed from our tumor registry. Stages were assigned by AJCC 7th edition. A comparison between the ECF regimen and non-ECF chemoradiation regimens was performed to view patterns of pathologic complete response (pCR), recurrence, toxicity and overall survival. Results: Forty-two patients were identified and stratified into two groups; Group 1 ECF treatment arm (n = 16) compared to group 2 non-ECF chemo-radiation arm (n = 26). No statistical difference was noted in age, ethnicity or stage stratification. All of Group 1 received their chemotherapy regimen after 2005. In contrast, 60% of Group 2 patients received their treatment pre-2005. Only 56% the ECF group completed their treatment course (19% received other postoperative therapy). Seventy percent of group 2 received adjuvant chemotherapy. A grade 2 or higher toxicity was noted in 16% of Group 1 compared to 60% in Group 2 (p = 0.035). Seven complications were noted in the group 1 compared to 10 in group 2 (p = NS). The differentiation of tumor between groups was not significant (p = 0.97). Length of stay was significant (Group 1:9 days, Group 2:12 days, p = 0.02). More nodes were retrieved from group 1 versus group 2 (20.2 versus 15.2, p = 0.03). Group 1 had 3 recurrences (19%) while Group 2 had 11 recurrences (42%, p = 0.94). In both groups 80% of recurrences were distant. Group 1 had a 19% pCR versus 23% in group 2 (p = 0.79). Two-year survival was 70% in both groups, with a median survival of 51 months for group 2. Median survival was not reached for group 1. Conclusions: No difference was noted in pCR, recurrences, or survival between these two regimens. If this can be confirmed in larger, prospective, randomized trials, use of radiation and its potential morbidity may be avoided. No significant financial relationships to disclose.

scholarly journals The role of postoperative radiotherapy after radical mastectomy in treatment of early breast cancer

2002 ◽  
Vol 10 (1) ◽  
pp. 7-12
Author(s):  
Jasmina Mladenovic ◽  
Nenad Borojevic
Keyword(s):  
Breast Cancer ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Local Recurrence ◽  
Postoperative Radiotherapy ◽  
Radical Mastectomy ◽  
Distant Metastases ◽  
Regional Lymph Nodes ◽  
Postoperative Irradiation

BACKGROUND: Radical or modified radical mastectomy was considered for many years the standard therapy for operable patients. Following radical mastectomy, postoperative irradiation of the chest wall and peripheral lymphatics is indicated in selected highrisk patients. Some studies on breast cancer patients who underwent radical mastectomy and received adjuvant chemotherapy tried to find out whether the addition of irradiation treatment to the chest wall and regional lymph nodes increases survival. The hypothesis in favor of irradiation is that chemotherapy can eliminate distant micrometastases, but is less effective against local and regional diseases, which are better controlled by radiotherapy. METHODS: In one year period, 110 patients with early stage of breast cancer were treated with radical mastectomy, and postoperative radiotherapy. Forty one patients had only postoperative radiotherapy, 27 received also adjuvant chemotherapy, 40 received adjuvant hormonal therapy and 2 patients received both adjuvant chemo and hormonotherapy. Postoperative irradiation was given on the regional lymph nodes (supra and infraclavicular, axillary and internal mammary nodes) with the tumor dose 48 Gy in 22 fractions over a period of four and a half weeks. All fields were treated with Cobalt 60. RESULTS After the median follow up of 67 months, 33 patients (30 %) had some kind of failure in form of local recurrence, distant metastases or both Locoregional relapse alone or associated with distant metastases occurred in 10 patients (9.1 %). Only 1.8 % of patients had local recurrence as the first failure. Distant metastases occurred in 32 patients (29.1%). After the end of follow up, 60 % patients are alive without evidence of disease while 16.4 % patients are alive with disease. The 5 year overall survival rate was 78.19% and 5 year disease free survival rate was 67.44%. CONCLUSION: Postoperative radiotherapy after radical mastectomy has important role in adjuvant treatment of early breast cancer in combination with adjuvant chemotherapy and hormonotherapy.

Adjuvant chemotherapy after trimodality therapy in locally advanced esophageal cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 144-144
Author(s):  
Divya Yerramilli ◽  
Davendra Sohal ◽  
Ursina R. Teitelbaum ◽  
Paul Stephen Wissel ◽  
Nevena Damjanov ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Adjuvant Chemotherapy ◽  
Clinical Outcomes ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Preoperative Chemoradiation ◽  
Hematologic Toxicity ◽  
Advanced Esophageal Cancer ◽  
Trimodality Therapy ◽  
Locally Advanced Esophageal Cancer

144 Background: The benefit of adjuvant chemotherapy after preoperative chemoradiation and surgery is unclear in patients with locally advanced esophageal cancer. We studied the toxicities and clinical outcomes in patients treated with or without adjuvant chemotherapy (CTX) after trimodality therapy. Methods: Records of patients with T3+ or N+ esophageal cancer who received preoperative chemoradiation followed by surgical resection from 2003-2013 were reviewed. Patients with postoperative deaths or poor performance status within 3 months after surgery were excluded (n = 13). Tolerability and hematologic toxicities of adjuvant CTX were recorded. Clinical outcomes of patients treated with adjuvant CTX were compared with a cohort of patients who received no further therapy (NFT). Results: Of the 81 trimodality patients included in the study, 53 received CTX and 28 received NFT after surgery. Median follow-up time was 23 months. FOLFOX (34%), cisplatin/5-FU (15%), 5-FU/LV (15%), ECF (13%), and carboplatin/paclitaxel (9%) were the most commonly used adjuvant regimens. Multiple rationales for adjuvant CTX were cited, including pathologic nodal status (32%), favorable pathologic response (61%), and provider preference (51%). Grade III/IV hematologic toxicity occurred in 11% of the CTX group: leukopenia (8%/2%), neutropenia (4%/4%), and thrombocytopenia (2%/0%). Two patients in the CTX group did not complete their prescribed CTX, which was discontinued after 1 cycle. Patient and clinical characteristics between CTX and NFT patients were well-balanced, except for pathologic complete response (pCR) rates (CTX 25% vs. NFT 50%, p=0.03). Three-year OS and DFS were similar between CTX and NFT patients (74% vs 70%, 60% vs. 64%, respectively). In patients who achieved pCR (33% overall), adjuvant CTX was associated with an improved 3-yr OS (86% vs. 62%), but the difference did not reach statistical significance (p=0.22). Distant failures occurred in 11% of the CTX group and 18% of the NFT group. Conclusions: Adjuvant CTX after trimodality therapy in esophageal cancer is feasible and well-tolerated with encouraging clinical outcomes. Further studies are needed to define the role of adjuvant CTX in these patients.

Combined Intraperitoneal and Intravenous Chemotherapy for Women With Optimally Debulked Ovarian Cancer: Results From an Intergroup Phase II Trial

2003 ◽  
Vol 21 (7) ◽  
pp. 1313-1319 ◽  
Author(s):  
Mace L. Rothenberg ◽  
P.Y. Liu ◽  
Patricia S. Braly ◽  
Sharon P. Wilczynski ◽  
Edward V. Hannigan ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Survival Rate ◽  
Survival Time ◽  
Median Survival ◽  
Phase Ii ◽  
Median Survival Time ◽  
Phase Ii Trial ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free

Purpose: The median survival time for women with optimally debulked adenocarcinoma of the ovary treated with intravenous (IV) chemotherapy is 41 to 52 months, and the 2-year survival rate is 65% to 70%. Recent studies evaluating intraperitoneal (IP) chemotherapy have reported a median survival time of 49 to 63 months and 2-year survival rates of 70% to 80%. This phase II trial was undertaken to evaluate the feasibility of and 2-year survival rate achieved by the combination of IP paclitaxel, IP cisplatin, and IV paclitaxel in women with optimally debulked, stage III ovarian cancer. Patients and Methods: Treatment consisted of paclitaxel 135 mg/m2 IV over 24 hours on days 1 to 2, cisplatin 100 mg/m2 IP on day 2, and paclitaxel 60 mg/m2 IP on day 8 administered every 21 days for six cycles. Results: In 68 assessable women with optimal stage III ovarian cancer, the 2-year survival rate was 91%, and the median survival time was 51 months. The 2-year disease-free survival rate was 66%, and median disease-free survival time was 33 months. Ninety-six percent of all patients experienced at least one grade 3 to 4 adverse event during therapy, with the most common events being neutropenia (79%), nausea (50%), vomiting (34%), and fatigue/malaise/lethargy (24%). Seventy-one percent of patients completed all six cycles of IV/IP therapy as planned. Conclusion: Combined IV and IP chemotherapy with cisplatin and paclitaxel is associated with a very promising 2-year survival rate in women with optimally debulked ovarian cancer. The ultimate impact of this approach on overall survival requires further evaluation in a randomized trial setting.

Phase II study of preoperative radiation with concurrent capecitabine, oxaliplatin, and bevacizumab followed by surgery and postoperative 5-FU, leucovorin, oxaliplatin (FOLFOX), and bevacizumab in patients with locally advanced rectal cancer: A trial of the Eastern Cooperative Oncology Group (E3204).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3605-3605
Author(s):  
Steven J. Cohen ◽  
Yang Feng ◽  
Jerome Carl Landry ◽  
Charles A. Staley ◽  
Richard Whittington ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase Ii ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Clinical Staging ◽  
Preoperative Treatment ◽  
Postsurgical Complications

3605 Background: Oxaliplatin and bevacizumab potentiate the antitumor activity of fluoroyprimidines and radiotherapy in preclinical and clinical studies of colorectal cancer. This phase II trial evaluated the efficacy of the preoperative combination of capecitabine, oxaliplatin, and bevacizumab with radiotherapy in rectal cancer. Methods: Eligibility: resectable T3/T4 adenocarcinoma of the rectum ≤ 12 cm. from anal verge. Preoperative treatment was capecitabine (825 mg/m² bid M-F), oxaliplatin (50 mg/m² weekly), bevacizumab (5 mg/kg D1,15,29), and pelvic external beam radiotherapy (50.4 Gy/28 fractions). Surgery was performed within 6-8 weeks. Within 12 weeks of surgery, patients received 12 cycles of FOLFOX + bevacizumab (5 mg/kg) Q2 weeks. Pathologic complete response (path CR) was the primary endpoint. Secondary endpoints included resection rate and toxicity. Results: Fifty-seven patients (pts) enrolled from 7/06 to 5/10 and 54 were eligible. Clinical staging: T3/4 (50/4), NX0/1/2 (2/16/31/5). Most common grade 3/4 non-hematologic toxicities during treatment were rectal pain (9), fatigue (8), and diarrhea (7). Two patients died of aspiration. Nine pts had early postsurgical complications (9 wound infections, 6 dehiscence, 1 abscess) and 23 had late surgical complications (23 non-healing wounds, 12 dehiscence, 5 bowel obstruction/ileus, 2 abscess). Pathologic staging: T0/1/2/3 (11/3/15/19), N0/1/2 (32/10/7). Nine pts had path CRs (17%, 90% CI:[9%-27%]. Surgery was LAR (38) and APR (11). Twenty-two pts did not receive postoperative chemotherapy (39%), 16 due to adverse events. Five local recurrences have been reported. RFS and OS data are immature. Conclusions: The addition of oxaliplatin and bevacizumab to capecitabine and radiotherapy for locally advanced rectal cancer resulted in downstaging for the majority of pts but did not improve the pathologic complete response rate compared to historical controls. The combination resulted in significant early and late postsurgical complications.

Neoadjuvant chemotherapy with gemcitabine and S-1 for resectable and borderline pancreatic ductal adenocarcinoma: A prospective, multi-institutional, phase II trial.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 283-283 ◽  
Author(s):  
Masamichi Mizuma ◽  
Fuyuhiko Motoi ◽  
Kazuyuki Ishida ◽  
Fumiyoshi Fujishima ◽  
Shigeru Ottomo ◽  
...  
Keyword(s):  
Survival Rate ◽  
Neoadjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Surgical Resection ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Distant Metastases ◽  
Ductal Adenocarcinoma ◽  
Institutional Setting ◽  
Resection Rate

283 Background: Although surgical resection is the only curative treatment for pancreatic ductal adenocarcinoma (PDAC), recurrence rates are very high even if complete resection is performed. Accordingly, a new therapeutic strategy against PDAC is needed. Combination with gemcitabine and S-1 (GS) as first line chemotherapy is promising. The purpose of this study is to evaluate the feasibility and efficacy of GS for resectable and borderline PDAC in the neoadjuvant chemotherapy (NAC). Methods: This study is a prospective, multi-institutional, single-arm, phase II trial. Neoadjuvant chemotherapy with gemcitabine and S-1(NAC-GS) for resectable and borderline PDAC was performed as follows. Gemcitabine was given at a dose of 1,000 mg/m2 on days 1 and 8 of each cycle. S-1 was administered orally at a dose of 40 mg/m2 twice daily for the first 14 consecutive days followed by a 7-day rest. Each cycle was repeated every 21 days. The primary endpoint was the 2-year survival rate. Secondary endpoints were feasibility, resection rate, pathological effect, recurrence-free survival and tumor marker status. Results: 36 patients were enrolled between 2008 and 2010. 35 were eligible for participation in this trial. The most common toxicity was neutropenia in response to 90% of the relative dose intensity. Radiological tumor shrinkage and decreases of CA19-9 levels were seen in 69% and 89%, respectively. R0 resection rate was 87%, and the morbidity rate (40%) was acceptable. The 2-year survival rate of the total cohort was 45.7%. Patients undergoing surgical resection without distant metastases after NAC-GS (n=27) showed an increased median overall survival (34.7 months), compared with 10.0 months for resection with distant metastases or non-resection (p=0.0017). Conclusions: NAC-GS is safe and well tolerated in a multi-institutional setting. NAC-GS is encouraging patients with resectable and borderline PDAC because of better outcomes. Clinical trial information: UMIN-000001504.

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