Doxifluridine and leucovorin: an oral treatment combination in advanced colorectal cancer.

1995 ◽  
Vol 13 (10) ◽  
pp. 2613-2619 ◽  
Author(s):  
E Bajetta ◽  
M Colleoni ◽  
M Di Bartolomeo ◽  
R Buzzoni ◽  
F Bozzetti ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Confidence Interval ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Response Duration ◽  
World Health ◽  
Median Response

PURPOSE This study was designed to test the activity and feasibility of an all-oral regimen of levo-leucovorin and doxifluridine (dFUR) in the treatment of advanced colorectal cancer and to establish whether the pharmacokinetics of dFUR and fluorouracil (FU) are affected by demographic and/or biologic parameters. MATERIALS AND METHODS One hundred eight patients with histologically proven colorectal cancer received orally administered levo-leucovorin 25 mg followed 2 hours later by dFUR 1,200 mg/m2 on days 1 to 5, with the cycle being repeated every 10 days. RESULTS Among 62 previously untreated patients, two complete responses (CRs) and 18 partial responses (PRs) were observed (overall response rate, 32%; 95% confidence interval, 21% to 45%). The median response duration was 4 months (range, 2 to 13) and the median survival time, 14 months. Among 46 pretreated patients, there were three CRs and three PRs (response rate, 13%; 95% confidence interval, 5% to 26%). In this group of patients, the median response duration was 4 months (range, 1 to 12) and the median survival time, 12 months. No toxic deaths were observed. The only World Health Organization (WHO) grade 3 to 4 side effect was diarrhea (32 patients). CONCLUSION This regimen is active in previously untreated colorectal cancer patients and combines good compliance with safety. Limited but definite efficacy was also detected in the patients previously treated with FU, which suggests incomplete cross-resistance between the two drugs. The pharmacokinetic results suggest that the conversion rate of dFUR to FU increases between days 1 and 5, but that FU levels remain low in comparison to those measured after classical FU therapy. Under the experimental conditions used in this study, the interpatient variability of pharmacokinetic parameters remains largely unexplained by the tested variables.

Phase II study with the combination etoposide, doxorubicin, and cisplatin in advanced measurable gastric cancer.

1989 ◽  
Vol 7 (9) ◽  
pp. 1310-1317 ◽  
Author(s):  
P Preusser ◽  
H Wilke ◽  
W Achterrath ◽  
U Fink ◽  
L Lenaz ◽  
...  
Keyword(s):  
Survival Time ◽  
Median Survival ◽  
Phase Ii ◽  
Metastatic Disease ◽  
Median Survival Time ◽  
Response Rate ◽  
Response Duration ◽  
World Health ◽  
Who Grade ◽  
Median Response

In this phase II multicenter trial, 67 evaluable patients with advanced measurable gastric carcinoma were treated with a combination of etoposide, Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and cisplatin (EAP). The overall response rate was 64%, including 21% complete responses (CRs). In 55 patients with metastatic disease, 31 responses (51%) including eight CRs (15%) were achieved. Responses were seen in all metastatic sites, but the response rate was lower in patients with peritoneal carcinomatosis. In 12 patients with locoregional disease, six CRs and six partial responses (PRs) were observed. Eight CRs (three and five in patients with metastatic and locoregional disease, respectively) were pathologically confirmed. The overall median response duration was 7 months; it was 16 months for patients achieving CR (22 months for pathologically confirmed CR [pCR]), and 6 months for PR. The median survival time for all patients was 9 months, for the patients who achieved CR 17 months, for pCR 23 months, and for PR 9.5 months. Median survival time for all patients with metastatic disease was 8 months, and for locoregional disease 12.5 months. Six patients (9%) (four local, two metastatic disease) were alive at 2 years, and four patients are alive and disease free at 35+ to 56+ months. Main toxicities were leukopenia and thrombocytopenia, with 64% of patients developing grade 3 to 4 myelosuppression and 12% severe infections. Nonhematologic toxicities of World Health Organization (WHO) grade 4 were not observed.

Tegafur combined with oxaliplatin and 5-FU versus FOLFOX4 for advanced colorectal cancer: a randomized controlled study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13566-13566
Author(s):  
L. Lingxiang ◽  
S. Yongqian ◽  
L. Ping ◽  
H. Puwen ◽  
Y. Yongmei
Keyword(s):  
Colorectal Cancer ◽  
Survival Time ◽  
Median Time ◽  
Side Effect ◽  
Median Survival Time ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Time To Progression ◽  
Group A ◽  
Group B

13566 Background: To determine the activity and side-effect of tegarfur injection combined with L-OHP and 5-FU, comparing with FOLFOX4 as the therapy for advanced colorectal cancer. Methods: 60 patients, proved pathologically, were divided into 2 groups at random. Group A received the intravenous administration of tegafur(800mg/m2 IV 3hrs qd d1–5),leucovorin(100mg/m2 IV 2hrs qd d1–5) and L-OHP(130mg/m2 IV 2hrs d1) every 21 days. FOLFOX4 was applied in the group B. The endpoint included response rate (RR), progression free survival (PFS), overall survival(OS) and quality of life(QOL). Results: The response rate was 39.3% in the group A, while median time to progression was 9.5 months with median survival time of 11.6 months. In the group B, the response rate was 48.1% and median time to progression was 9.4 months with median survival time of 12.1 months. No significant differences were found between treatment arms in curative effect, survival time and side effect(P>0.05). With respect to QOL, the group A achieved higher PS than B during treatment (P<0.001). Conclusions: The intravenous administration of tegafur, leucovorin and L-OHP is a well-tolerated, effective, and feasible schedule for advanced colorectal cancer that yields comparable efficacy and side effect compared with FOLFOX4. Meanwhile, the former achieves the better QOL. No significant financial relationships to disclose.

Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: a Gynecologic Oncology Group study.

1998 ◽  
Vol 16 (2) ◽  
pp. 405-410 ◽  
Author(s):  
P G Rose ◽  
J A Blessing ◽  
A R Mayer ◽  
H D Homesley
Keyword(s):  
Ovarian Carcinoma ◽  
Survival Time ◽  
Median Survival Time ◽  
Response Rate ◽  
Response Duration ◽  
Oral Etoposide ◽  
Median Response ◽  
Platinum Sensitive ◽  
Platinum Resistant ◽  
Grade 3

PURPOSE A phase II trial was conducted to determine the activity of prolonged oral etoposide in platinum-resistant and platinum-sensitive ovarian carcinoma. PATIENTS AND METHODS Platinum-resistant disease was defined as progression on platinum-based chemotherapy or recurrence within 6 months of completing therapy. The starting dose was 50 mg/m2/d (30 mg/m2/d for prior radiotherapy) for 21 days, every 28 days. A dose escalation to a maximum dose of 60 mg/m2/d was prescribed. RESULTS Of 99 patients entered, 97 were assessable for toxicity and 82 were assessable for response. Among 41 platinum-resistant patients a 26.8% response rate (7.3% complete response [CR] and 19.5% partial response [PR] rate) occurred. The median response duration was 4.3 months (range, 1.3 to 8.7), median progression-free interval (PFI) was 5.7 months (range, 0.8 to 30.8+), and median survival time was 10.8 months (range, 1.9 to 45.8). Twenty-five of 41 platinum-resistant patients had also previously received paclitaxel; of which eight (32%) responded. Among 41 platinum-sensitive patients, a 34.1% response rate (14.6% CR and 19.5% PR rate) occurred. The median response duration was 7.5 months (range, 1.9 to 15.2+), median PFI was 6.3+ months (range, 0.9 to 20.4), and median survival time was 16.5+ months (range, 0.9 to 34.8). Of 97 patients assessable for toxicity, grade 3 or 4 hematologic toxicity was common, with leukopenia occurring in 41.2% (grade 3, 29%; grade 4, 12%), neutropenia in 45.4% (grade 3, 20%; grade 4, 25%), thrombocytopenia in 9% (grade 3, 5%; grade 4, 4%), and anemia in 13.4%. Three treatment-related deaths occurred: two from neutropenic sepsis and one from thrombocytopenic bleeding after an overdose. One patient developed leukemia. CONCLUSION This regimen is active in platinum-resistant and platinum-sensitive ovarian carcinoma. Additionally, the regimen is active in paclitaxel-resistant ovarian carcinoma.

Combined doxorubicin and cyclophosphamide chemotherapy for nonresectable feline fibrosarcoma

2000 ◽  
Vol 36 (5) ◽  
pp. 416-421 ◽  
Author(s):  
LG Barber ◽  
KU Sorenmo ◽  
KL Cronin ◽  
FS Shofer
Keyword(s):  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Progressive Disease ◽  
Response Duration ◽  
Tumor Burden ◽  
Retrospective Evaluation ◽  
Median Response

A retrospective evaluation was performed on 12 cats with nonresectable, histopathologically confirmed fibrosarcomas that were treated with doxorubicin and cyclophosphamide chemotherapy. All of the tumors were located in sites potentially used for vaccination. Six cats had a greater than 50% decrease in gross tumor burden. However, the responses were not durable, with a median response duration of 125 days. All cats developed progressive disease. When animals that received other treatments after doxorubicin-based chemotherapy were eliminated from the analysis, median survival time was significantly longer for cats that responded to chemotherapy compared with the median survival time for nonresponders (242 and 83 days, respectively). These findings may serve as a basis for further evaluating the role of chemotherapy in the treatment of vaccine-associated sarcomas.

Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy.

1997 ◽  
Vol 15 (1) ◽  
pp. 251-260 ◽  
Author(s):  
P Rougier ◽  
R Bugat ◽  
J Y Douillard ◽  
S Culine ◽  
E Suc ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Objective Response ◽  
World Health ◽  
Who Grade ◽  
Pretreated Patients ◽  
Grade 3

PURPOSE To assess the efficacy of irinotecan (CPT-11) in the treatment of advanced colorectal cancer in both chemotherapy-naive and pretreated patients. PATIENTS AND METHODS Two hundred thirteen patients (aged 18 to 75 years) with metastatic colorectal cancer, World Health Organization (WHO) performance status < or = 2, and life expectancy > or = 3 months were treated with CPT-11 350 mg/m2 every 3 weeks. All 178 patients eligible for efficacy analysis had not received more than one prior fluorouracil (5-FU)-based chemotherapy regimen (adjuvant or palliative) and had adequate hematologic, renal, and hepatic function. RESULTS Primary tumor sites were the colon (71%) and rectum (28%). Sixty-six percent of the patients had > or = two metastatic sites. Ninety-eight percent of the patients had undergone previous surgery, and 77.5% had received prior chemotherapy. Thirty-two of 178 eligible patients achieved on objective response (four complete responses [CRs] and 28 partial responses [PRs]; response rate, 18%; 95% confidence interval, 12.6% to 24.4%), 65 were stable, and 59 progressed. The response rate was 17.7% in the pretreated group and 18.8% in the chemotherapy-naive group. Within the former subgroup, response rates of 16.1% were reported in patients who were progressive on prior 5-FU chemotherapy and 19.1% in patients who were progressive off such treatment. The median duration of objective response (9.1 months) and median time to achievement of a response (9.3 weeks) did not differ between chemotherapy-naive and pretreated patients. The most frequent adverse events were neutropenia, which developed in 80% of the patients, delayed diarrhea (87%), alopecia (88%), fatigue (81%), and nausea/vomiting (77%). All these adverse events were manageable. Severe (WHO grade 3 or 4) neutropenia was only observed in 18% of the cycles, leukopenia in 11%, delayed diarrhea in 11%, and nausea and vomiting in 3%. Development of simultaneous grade 3 or 4 neutropenia and delayed diarrhea during 4% of the cycles was the safety issue of greatest concern. CONCLUSION CPT-11 has definite activity in the treatment of advanced metastatic colorectal cancer both in chemotherapy-naive and in pretreated patients who experienced disease progression on 5-FU, which suggests a lack of cross-resistance between CPT-11 and 5-FU. Diarrhea and neutropenia, the major toxicities of CPT-11, contribute to the risk to develop febrile neutropenic sepsis.

Phase II clinical study of combination therapy with irinotecan and S-1(IRIS) for inoperable recurrent advanced colorectal cancer: Hokkaido Gastrointestinal Cancer Study Group study HGCSG-0302)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3589-3589
Author(s):  
Y. Komatsu ◽  
S. Yuki ◽  
H. Akita ◽  
M. Kudo ◽  
M. Tateyama ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Study ◽  
Combination Therapy ◽  
Survival Time ◽  
Phase Ii ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Dose Intensity ◽  
Outpatient Basis ◽  
Phase Ii Clinical Study

3589 Background: We planned to conduct a phase II clinical study of combination therapy with irinotecan and S-1, a new oral anticancer drug of the fluorinated pyrimidine type. We reported the interium reports of this study in colorectal cancer patients at GI cancer Symposium 2006. Methods: The antitumor effect was the primary endpoint, while the safety, progression-free survival time, and median survival time were the secondary endpoints. The subjects were untreated patients with inoperable advanced colorectal cancer aged 20–75 years. Irinotecan was administered at a dose of 100 mg/m2 (on days 1 and 15) as an intravenous infusion over 90 minutes, and oral S-1 (40 mg/m2) was administered after breakfast and dinner and then withdrawn for 2 weeks. Results: Forty patients were enrolled in the present study. There were 23 men and 17 women. The median age was 62 years (range: 34 to 74 years). Two patient showed grade 4 neutropenia, but the next course could be given safely after dose reduction. Three patients had grade 3 diarrhea, but therapy could be continued with addition of an antidiarrheal drug. No other serious adverse reactions occurred (either hematological or non-hematological), and all patients could receive therapy safely on an outpatient basis. Interim analysis suggested excellent results, with a response rate of 50%. To date, 231 cycles (median 8, range 1–19) have been administered. Median relative dose intensity was 97% for S-1 and 87% for irinotecan. 36 pts are evaluable for efficacy: RR was 47.2% (95% CI, 30.9–63.5%) and Disease Control Rate (PR + SD) was seen in 94.4% of pts. PFS of this regimen is 320 days. MST is not reached. Conclusions: IRIS therapy achieved a high response rate and could be given safely. These findings suggest that the therapy has potential as first-line treatment for inoperable advanced recurrent colorectal cancer. It seems that IRIS is a good treatment equal to FOLFIRI. In addition, this regimen could qualify as a candidate for future combination therapy with a molecular-targeting drug. The latest data will be reported at the meeting. No significant financial relationships to disclose.

Radiation therapy in the treatment of canine and feline thymomas: a retrospective study (1985-1999)

2001 ◽  
Vol 37 (5) ◽  
pp. 489-496 ◽  
Author(s):  
AN Smith ◽  
JC Wright ◽  
Brawner WRJr ◽  
SM LaRue ◽  
L Fineman ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Retrospective Study ◽  
Survival Time ◽  
Median Survival ◽  
Stable Disease ◽  
Tumor Size ◽  
Median Survival Time ◽  
Overall Response Rate ◽  
Response Rate ◽  
Clinical Signs

A retrospective study was performed of 17 dogs and seven cats with various stages of thymoma treated with radiation alone or as an adjunctive therapy. Analysis revealed an overall response rate of 75% (15/20 evaluable cases). Partial (i.e., &gt;50% reduction in tumor size) and complete (i.e., no detectable tumor) responses were included. Complete responses were rare (4/20). Three of five animals with stable disease (i.e., &lt;50% change in tumor size) had improvements in clinical signs, despite lack of measurable response. A median survival time of 248 days (range, 93 to 1,657+ days) was achieved in dogs, and a median survival time of 720 days (range, 485 to 1,825+ days) was achieved in cats. Radiation therapy appears to be useful in the management of invasive thymomas in dogs and cats.

Randomized Multicenter Phase II Trial of Two Different Schedules of Capecitabine Plus Oxaliplatin as First-Line Treatment in Advanced Colorectal Cancer

2003 ◽  
Vol 21 (7) ◽  
pp. 1307-1312 ◽  
Author(s):  
Werner Scheithauer ◽  
Gabriela V. Kornek ◽  
Markus Raderer ◽  
Birgit Schüll ◽  
Katharina Schmid ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Survival Time ◽  
Phase Ii ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Progression Free Survival ◽  
Synergistic Activity ◽  
Free Survival ◽  
Multicenter Phase ◽  
To Receive

Purpose: Capecitabine and oxaliplatin, two new agents with potential synergistic activity, have demonstrated promising antitumor efficacy in advanced colorectal cancer (ACC). Preclinical and clinical evidence indicating that dose intensification of the oral fluorouracil prodrug might result in improved therapeutic results led us to the present randomized multicenter phase II study. Patients and Methods: Eighty-nine patients with bidimensionally measurable ACC previously untreated for metastatic disease were randomly allocated to receive oxaliplatin 130 mg/m2 day 1 plus capecitabine 2,000 mg/m2/d days 1 to 14 every 3 weeks (arm A) or to receive oxaliplatin 85 mg/m2 days 1 and 14 combined with capecitabine 3,500 mg/m2 days 1 to 7 and 14 to 21 every 4 weeks (arm B). In both treatment arms, chemotherapy was continued for a total of 6 months unless there was prior evidence of progression of disease. Results: Patients allocated to the high-dose capecitabine combination arm B had a higher radiologically confirmed response rate (54.5% v 42.2%) and a significantly longer median progression-free survival time than those allocated to control arm A (10.5 v 6.0 months; P = .0013). Median overall survival times cannot be calculated for either treatment arm at this point. Despite a 34% higher dose intensity of capecitabine in arm B, there was no difference in hematologic toxicity between treatment arms (neutropenia/thrombocytopenia: 60%/43% in arm B v 56%/33% in arm A). Similarly, the incidence rate and degree of nonhematologic adverse events were comparable: The most commonly encountered symptoms (all grades, arm A and arm B) included nausea/emesis (A: 58%; B: 62%), diarrhea (A: 44%; B: 31%), peripheral sensory neuropathy (A: 80%; B: 83%), and fatigue (A: 40%; B: 50%). Conclusion: Results of this study indicate that both combination regimens are feasible, tolerable, and clinically active. The dose-intensified bimonthly capecitabine arm, however, seems to be more effective in increasing both response rate and progression-free survival time.

Treatment of metastatic breast cancer in premenopausal women using CAF with or without oophorectomy: an Eastern Cooperative Oncology Group Study.

1987 ◽  
Vol 5 (6) ◽  
pp. 881-889 ◽  
Author(s):  
G Falkson ◽  
R S Gelman ◽  
D C Tormey ◽  
C I Falkson ◽  
J M Wolter ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Response Rate ◽  
Metastatic Breast ◽  
Premenopausal Women ◽  
Prior Chemotherapy ◽  
Er Positive

One hundred thirty-one premenopausal women with metastatic breast cancer who had received no prior systemic treatment for metastases were entered on study. Patients without prior chemotherapy with estrogen receptor (ER)-positive and ER-unknown disease were randomized to receive cyclophosphamide, Adriamycin (Adria Laboratories, Columbus, OH), and 5-fluorouracil (CAF) or surgical oophorectomy followed directly by CAF (O + CAF). ER-negative patients without prior chemotherapy were directly assigned to treatment with CAF. Among randomized patients 83% have responded, and 37% have achieved a complete remission. Among ER-negative patients the complete response rate was 38%, and the complete plus partial response rate was 70%. Characteristics significantly associated with a longer time to treatment failure were age 45 or over, one or two organ sites, and performance status O. The median survival time of ER-positive patients treated with CAF is 29 months, and with O + CAF it has not yet been reached, whereas for ER-unknown patients the equivalent survival times are 41 months and 43 months respectively. For ER-negative patients treated with CAF the median survival time is 17 months. Characteristics associated with significantly longer survival among randomized patients were age 35 or over (P = .009) and only one or two organ sites involved (P = .02). Neither treatment (P = .33) nor ER status (P = .70) was significant.

Five-year survival analysis of liver metastasis of colorectal cancer after hepatic resection

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14571-14571
Author(s):  
J. Xu ◽  
Y. Zhong ◽  
J. Fan ◽  
J. Zhou ◽  
J. Zhou ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Survival Rate ◽  
Liver Metastasis ◽  
Hepatic Resection ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Operative Therapy ◽  
Metachronous Liver Metastasis ◽  
First Choice

14571 Background: To evaluate the relation between hepatic resecion and survival rate of liver metastasis of colorectal cancer ( LMCC). Methods: Use retrograde case analysis method, 133 cases of LMCC received hepatic resection from 1/1/2000 to 31/12/2005 were included,with attention to the relation between hepatic resection and survival rate. Results: There were 133 cases underwent curative hepatic resection in all 470 LMCC cases, of which 30 cases (30/196,15.3%) in synchronous liver metastasis (SLM) group and 103 cases (103/274,37.6%) in metachronous liver metastasis (MLM) group, P<0.01. Mortality rate related to operation was 3.3%(1/30) in SLM and 1.9%(2/103) in MLM(P<0.05). Until 31/6/2006, all 133 cases were followed-up, 1,3,5 years survival rate and median survival time of SLM (81.0%, 40.3%, 16.5%, 22 months) is similar to that of MLM (88.2%, 49.1%, 31.7%, 25 months, P > 0.05), but the recurrence rate is higher(36.7% vs 20.4%,P=0.03). Compared to 49 cases whose liver metastases focus can be resected but chosen non- operative therapy, 1, 3, 5 years survival rate of 133 resected cases is higher (55.6%, 11.0%, 0 vs 86.2%, 39.2%, 29.4%, P=0.0034). In SLM, 22 cases received I stage resection of the primary colorectal tumor and liver metastasis and 8 cases received liver metastasis resection after the primary surgery (II stage operation). 1, 2, 3 years survival are 90.0% vs 87.5%(P > 0.05),61.4% vs 55.3%(P > 0.05)and 35.4% vs 30.0%(P > 0.05) and the median survival time is 28 months vs 26months(P > 0.05).COX multivariate analysis was used to analyze the prognositic factors. Incision margin =1cm(β=-0.8351,P=0.0363)and reoperation after recurrence(β=- 0.9428,P=0.0411)were protective survival factors, and postoperation recurrence (β=0.6471,P=0.0226) was survival risk factor. Conclusions: Curative hepatic resection is the first choice of liver metastasis of colorectal cancer and can improve survival. No significant financial relationships to disclose.

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