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1.
Gianluca Tomasello Wanda Liguigli Rossana Poli Silvia Lazzarelli Matteo Brighenti Federica Negri Alessandra Curti Mario Martinotti Lucio Olivetti Massimo Rovatti Gianvito Donati Rodolfo Passalacqua 《Gastric cancer》2014,17(4):711-717
Background
We previously studied a dose-dense TCF (TCF-dd) regimen demonstrating its feasibility and an activity comparable to epirubicin-based chemotherapy and TCF q3w in terms of overall survival and time to progression (TTP). We report here the final results of a phase II study of chemotherapy with a modified TCF-dd regimen in locally advanced or metastatic gastric cancer (MGC).Methods and study design
Patients with histologically confirmed measurable MGC, not previously treated for advanced disease, received docetaxel 70 mg/m2 day 1, cisplatin 60 mg/m2 day 1, l-folinic acid 100 mg/m2 days 1 and 2, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus days 1 and 2, and then 600 mg/m2 as a 22-h continuous infusion days 1 and 2, every 14 days, plus pegfilgrastim 6 mg on day 3. Patients aged ≥65 years received the same schedule with a dose reduction of 30 %.Results
Study duration: December 2007–November 2010. Forty-six consecutive patients were enrolled (78 % male, 22 % female; median age, 66 years, range, 38–76 years; ECOG PS: 0, 48 %, 1, 46 %). Primary endpoint was overall response rate (ORR). A median of four cycles (range, one to six) was administered. Forty-three patients were evaluated for response (93.5 %) and all for toxicity: 3 complete response (CR), 25 partial response (PR), 10 stable disease (SD), and 5 progressive disease (PD) were observed, for an ORR by intention to treat (ITT) of 61 % (95 % CI 47–75). Median overall survival (OS) was 17.63 months (95 % CI, 13.67–20.67); median progression-free survival was 8.9 months (95 % CI, 6.5–13.4). Twenty-one patients (46.0 %) were treated at full doses without any delay, thus respecting the dose-dense criterion. Most frequent grade 3–4 toxicities were neutropenia (20 %), leukopenia (4 %), thrombocytopenia (2 %), anemia (2 %), febrile neutropenia (6 %), asthenia (22 %), diarrhea (4 %), nausea/vomiting (11 %), and hypokalemia (6 %). Overall, TCF-dd was shown to be safe.Conclusions
The TCF-dd regimen in locally advanced or MGC is confirmed to be feasible and very active and needs to be further tested in randomized studies. 相似文献2.
Agustin A. Garcia MD Lawrence Leichman Joaquina Baranda Lalita Pandit Heinz-Josef Lenz Cynthia G. Leichman 《Journal of gastrointestinal cancer》2003,34(2-3):79-86
Background. Advanced pancreatic cancer has limited treatment options. 5-fluorouracil (5-FU) is frequently used in the treatment of pancreatic cancer. Preclinical studies suggest synergism between trimetrexate (TMTX), 5-FU, and leucovorin (NFL). Aim. We conducted a phase II trial to evaluate the activity and safety of NFL in pancreatic cancer. Method. Eligible patients (n=21) with untreated advanced pancreatic cancer were treated with 110 mg/m2 intravenous (IV) THTX on day 1 and 200 mg/m2 IV leucovorin prior to 500 mg/m2 IV 5-FU on day 2. Oral leucovorin (15 mg every 6 h for seven doses) started intravenous 24 h later. Results. Treatment was administered for 6 wk followed by a 2-wk rest period. Response was evaluated every 8 wk. All patients were evaluable for response and toxicity. Most patients (80%) had distant metastases. Forty-five cycles of chemotherapy were administered. The most common serious toxicities were Grade 3 diarrhea (23.8%) and nausea and vomiting (14.2%). The response rate was 4.1% (95% CI, 0–23%), median survival was 6.8 mo, and 1-yr survival was 19%. Conclusion. Treatment with NFL is well-tolerated in patients with advanced pancreatic cancer. The median survival and 1-yr survival in these patients with poor prognosis compares favorably with other treatment options. 相似文献
3.
Emi M Hihara J Hamai Y Aoki Y Okada M Kenjo M Murakami Y 《Cancer chemotherapy and pharmacology》2012,69(6):1499-1505
Purpose
We aimed to evaluate the safety, tolerability, and efficacy of combination preoperative chemoradiotherapy as first-line treatment in patients with advanced esophageal cancer.Methods
We performed a phase I dose-escalation trial of docetaxel at 25–40?mg/m2 in four planned dose levels in 3–6 patient cohorts on days 1, 15, 29, and 43 administered in combination with cisplatin (70?mg/m2 on days 1 and 29) and 5-fluorouracil (70?mg/m2/day on days 1–4 and 29–32) and concurrent radiation therapy (40?Gy). The tumors were resected during weeks 10–13.Results
This study included 7 patients with esophageal cancer. The dose-limiting toxicity was observed at a biweekly docetaxel dose of 30?mg/m2 when patients developed grade 3 febrile neutropenia, grade 4 thrombocytopenia, and grade 4 pain/esophagus, resulting in a maximum tolerated dose of 25?mg/m2. Grade 3/4 hematological toxicity was observed in 71% of the patients and grade 3/4 non-hematological toxicity in 57%. The overall tumor response rate was 86% (complete, 57% and partial, 29%). All patients underwent surgery, and there were no deaths as a result of postoperative complications.Conclusions
This preoperative chemoradiotherapy regimen using triplets is feasible but results in moderate toxicity. It is noteworthy that this regimen was associated with a high rate of pathological complete remission. 相似文献4.
Hayashi T Ishiwatari H Yoshida M Sato T Miyanishi K Sato Y Kobune M Takimoto R Sonoda T Kato J 《International journal of clinical oncology / Japan Society of Clinical Oncology》2012,17(5):491-497
Background
Many clinical trials have been conducted with gemcitabine- or 5-fluorouracil-based regimens as treatment for unresectable biliary tract cancer; however, the results remain unsatisfactory. Because further therapeutic improvements are required, we conducted a phase I study of arterial infusion chemotherapy using a combination of gemcitabine and 5-fluorouracil.Methods
In the first 3 cohorts, patients were to receive an arterial infusion of gemcitabine 600, 800 or 1000?mg/m2, respectively, over 30?min on days 1 and 15, plus a continuous arterial infusion of 5-fluorouracil 300?mg/m2/day on days 1–5 and 15–19. In the final cohort, patients were to receive an arterial infusion of gemcitabine 1000?mg/m2 over 30?min on days 1 and 15, plus 5-fluorouracil 400?mg/m2/day on days 1–5 and 15–19.Results
Eighteen patients were enrolled. In the final cohort, three of six patients experienced grade 3 non-hematological toxicities (cholecystitis, cellulitis and pneumonia). Thus, we determined the maximum tolerated doses of gemcitabine and 5-fluorouracil in arterial infusion chemotherapy to be 1000 and 400?mg/m2, respectively.Conclusion
This regimen of gemcitabine and 5-fluorouracil is tolerable and warrants further investigation in biliary tract cancer. 相似文献5.
Sym SJ Hong J Jung M Park J Cho EK Lee WK Chung M Kim HS Lee JH Shin DB 《Cancer chemotherapy and pharmacology》2012,70(2):277-284
Purpose
This study was performed to determine the recommended dose (RD) and dose-limiting toxicity (DLT) associated with epirubicin, oxaliplatin, and S-1 (EOS) combination therapy in patients with previously untreated advanced gastric cancer (AGC).Materials and methods
Previously untreated patients with histologically proven metastatic AGC, with an ECOG performance status of 0?C2, were enrolled in this study. A fixed dose of epirubicin (50?mg/m2) and oxaliplatin (130?mg/m2) was intravenously administered on day 1 of treatment, followed by oral S-1 administration twice daily on days 1?C14. The S-1 dose was escalated according to the following schedule: level I, 35?mg/m2; level II, 40?mg/m2; level III, 45?mg/m2; Level IV, 50?mg/m2. Each cycle was repeated every 21?days. DLTs were evaluated during the first two cycles of treatment.Results
Nineteen patients with a median age of 53?years (range, 40?C71?years) were enrolled in this study. One case of DLT (grade 4 neutropenia lasting more than 5?days) developed from among the six dose level II patients, while 2 DLTs (grade 3 diarrhea and nausea) were observed among the 4 dose level III patients. Based on these results, dose level II was determined as the RD. Of the 13 patients with measurable lesions, eight achieved partial response, three showed stable disease, and the objective response rate was 61.5?% (95?% confidence interval (CI), 13.3?C66.6?%). The median progression-free survival and overall survival of all patients was 6.8?months (95?% CI, 1.4?C9.5?months) and 13.3?months (95?% CI, 1.9?C24.6?months), respectively.Conclusion
The RD of the EOS regimen in patients with previously untreated AGC was 50?mg/m2 of epirubicin and 130?mg/m2 of oxaliplatin on day 1, with administration of 40?mg/m2 of S-1 twice a day on days 1?C14 for each 21-day cycle. The EOS regimen described produced promising results. 相似文献6.
Catalano V Vincenzi B Giordani P Graziano F Santini D Baldelli AM Alessandroni P Schiavon G Rossi D Casadei V D'Emidio S Luzi Fedeli S Tonini G Fiorentini G 《Gastric cancer》2012,15(4):419-426
Background
The combination of docetaxel, cisplatin, and 5-fluorouracil (5-FU) has demonstrated a survival advantage over cisplatin and 5-FU, but with substantial hematological toxicity. We aimed to evaluate the efficacy and toxicity of a sequential regimen with cisplatin, leucovorin, and 5-FU (PLF) followed by docetaxel in metastatic gastric cancer patients.Methods
Treatment consisted of 4 cycles of biweekly PLF (cisplatin 50?mg/m2 as a 30-min infusion on day 1, leucovorin 200?mg/m2 in a 2-h infusion, and 5-FU 2,800?mg/m2 in a 48-h continuous infusion starting on day 1) followed, in cases of response or stable disease, by 3 cycles of docetaxel (75?mg/m2, every 3?weeks).Results
Thirty-four patients were enrolled, with an average age of 64?years (range 34–69). The main cumulative grade 3–4 toxicities were: neutropenia (38.2%), febrile neutropenia (11.8%), and fatigue (14.7%). After the planned 7 cycles of treatment, the overall response rate was 38.2% (95% confidence interval [CI] 21.9–54.6), with 3 complete and 10 partial responses. Median progression-free survival and overall survival were 4.8 and 10.6?months, respectively.Conclusions
For patients with metastatic gastric cancer, the sequential administration of cisplatin, leucovorin, 5-FU, and docetaxel may be an effective palliative option and offers a far more favorable toxicity profile than the simultaneous use of docetaxel, cisplatin, and 5-FU. 相似文献7.
Han Ying Bao Wei Jia Fang Xiao Chen Zhang Gen Ming Shi Sui Huang Lan Fang Yu Jin Chen Hai Bo Mou Jing Deng Peng Shen Nong Xu 《Cancer chemotherapy and pharmacology》2011,67(1):147-152
Purpose
To evaluate the efficacy and safety of FOLFIRI regimen in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.Methods
The FOLFIRI regimen consisted of intravenous infusion of irinotecan 180?mg/m2 on day 1 plus leucovorin (LV) 400?mg/m2 on day 1 plus 5-fluorouracil (5-FU) 400?mg/m2 bolus on day 1 plus 46-hour intravenous infusion of 5-FU 2,400?mg/m2, every 2?weeks as one cycle. The main selection criterion for this study was the advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.Results
Of the 57 evaluable patients for efficacy, 4 (7.5%) had a partial response, 36 (67.9%) had stable disease, and 13 (24.5%) had progressive disease. Median progression-free survival was 4.8?months (95% CI 3.9?C5.7?months), and median overall survival was 7.8?months (95% CI 13.1?C16.5?months). Safety analysis was based on the data of 57 evaluable patients. The most frequently observed grade 3 or 4 toxicities were neutropenia 16 (27.8%), nausea/vomiting 7 (12.3%), and diarrhea 1 (1.8%).Conclusion
FOLFIRI regimen is effective and well tolerated in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin in Chinese population. 相似文献8.
Tanaka Y Yoshida K Sanada Y Osada S Yamaguchi K Takahashi T 《Cancer chemotherapy and pharmacology》2010,66(6):1159-1165
Background and purpose
The optimal chemotherapeutic protocol for the treatment of esophageal cancer has not yet been established. A dose-escalation study of docetaxel combined with cisplatin and 5-fluorouracil (5-FU) was performed to determine the optimal dose in patients with advanced esophageal squamous cell carcinoma.Patients and method
We studied a total of 18 patients who had previously untreated thoracic esophageal squamous cell carcinoma with T4 tumors and/or metastasis. The patients received an infusion of docetaxel at different dose levels (levels 1, 2, 3: 30, 35, 40 mg/m2, respectively) and an infusion of cisplatin (40 mg/m2) on days 1 and 15 plus a continuous infusion of 5-FU (400 mg/m2/day) on days 1–5 and 15–19.Results
Dose-limiting toxicities (DLT) included febrile neutropenia and leukopenia. DLT occurred in 2 of 6 patients at level 1, 2 and in 3 of 6 patients at level 3. The response rate was 88.9%, including a complete response rate of 33.3%.Conclusions
To minimize toxicity and maximize dose intensity, we elected to investigate a biweekly regimen. The maximum tolerated dose was level 3, and the recommended dose was determined to be docetaxel 35 mg/m2 with cisplatin 40 mg/m2 plus 5-FU 400 mg/m2, administered biweekly. This regimen was tolerable and highly active. A phase II study has been started. 相似文献9.
Reni M Cereda S Rognone A Belli C Ghidini M Longoni S Fugazza C Rezzonico S Passoni P Slim N Balzano G Nicoletti R Cappio S Doglioni C Villa E 《Cancer chemotherapy and pharmacology》2012,69(1):115-123
Purpose
PEFG regimen (P:cisplatin, E:epirubicin, F:5-fluorouracil, G:gemcitabine) significantly prolonged progression-free (PFS) and overall survival (OS) of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine. The current trial was aimed at assessing whether the replacement of E with docetaxel (D) may improve 6?months PFS (PFS6).Methods
Chemo-naive patients with stage III or metastatic PA received P (30?mg/m2 day 1 and 15), G (800?mg/m2 day 1 and 15), and capecitabine (1,250?mg/m2/day?days 1?C28, without a break) and were randomized to receive either D at 25?C30?mg/m2 day 1 and 15 (arm A: PDXG regimen) or E at 30?mg/m2 day 1 and 15 (arm B: PEXG regimen). Cycles were repeated every 28?days for a maximum of 6?months. The Fleming design was used to calculate the sample size on the probability of being PFS6. Assuming P0?=?40% and P1?=?60%, ???=?0.05 and ???=?0.10; the study was to enroll 52 patients per arm.Results
Between July 2005 and September 2008, 105 patients were enrolled, stratified by stage and randomized. Patients?? characteristics were (A/B) the following: median age 61/59, PS?>70 92/88%, metastatic disease 66/65%. PFS6 was 58%, and median OS was 11?months in both arms. A partial response was observed in 60/37% of patients. Main per cycle G3-4 toxicity was the following: neutropenia 4/13%, thrombocytopenia 2/4%, anemia 4/4%, and fatigue 6/3%.Conclusions
The inclusion of D instead of E yielded more objective response and less G3-4 neutropenia but did not improve PFS and OS. The present trial confirms the relevant impact on outcome of advanced PA of 4-drug regimens. 相似文献10.
Sun Jin Sym Junshik Hong Jinny Park Eun Kyung Cho Jae Hoon Lee Yeon Ho Park Woon Ki Lee Min Chung Hyung-Sik Kim Se Hoon Park Dong Bok Shin 《Cancer chemotherapy and pharmacology》2013,71(2):481-488
Background
The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC).Methods
A total of 59 patients were randomly assigned to either CPT-11 (150 mg/m2 iv on day 1) or mFOLFIRI (CPT-11 150 mg/m2 plus LV 20 mg/m2 on day 1 followed by 5-FU 2,000 mg/m2 over 48 h), every 2 weeks. The primary end point was objective response rate (ORR).Results
Following random assignment, 29 patients received CPT-11 and 30 patients mFOLFIRI. The ORR was 17.2 % [95 % confidence interval (CI) 3.4–30.9] and 20.0 % (95 % CI 5.6–34.3) for the CPT-11 and mFOLFIRI arms, respectively (P = 0.525). There was no significant difference in median progression-free survival: 2.2 months (95 % CI 0.2–4.3) for CPT-11 versus 3.0 months (95 % CI 2.0–3.7) for mFOLFIRI (P = 0.481) or in median overall survival: 5.8 months (95 % CI 3.0–8.7), compared with 6.7 months (95 % CI 5.3–8.2) (P = 0.514). Grade 3/4 toxicity was observed in 21 and 28 events in the CPT-11 and mFOLFIRI arms, respectively.Conclusions
Although this study had a small sample size and limited statistical power, CPT-11 monotherapy and mFOLFIRI appear to be equally active and tolerable as second-line chemotherapy for AGC. The addition of 5-FU/LV to CPT-11 did not significantly improve efficacy. 相似文献11.
Eun Joo Kang Seock-Ah Im Do-Youn Oh Sae-Won Han Jin-Soo Kim In Sil Choi Jin Won Kim Yu Jung Kim Jee Hyun Kim Tae-You Kim Jong Seok Lee Yung-Jue Bang Keun-Wook Lee 《Gastric cancer》2013,16(4):581-589
Background
The aim of this study was to evaluate the activity and safety of the combination chemotherapy of 5-fluorouracil (5-FU), leucovorin, and irinotecan (FOLFIRI regimen) after failure of fluoropyrimidine, platinum, and taxane in gastric cancer (GC) and to evaluate the prognostic factors for survival.Methods
Patients received biweekly FOLFIRI chemotherapy as third-line treatment. The FOLFIRI-1 consisted of irinotecan (180 mg/m2 in a 2-h infusion) on day 1, and then leucovorin (200 mg/m2 in a 2-h infusion) and 5-FU (a 400 mg/m2 bolus, followed by 600 mg/m2 in a 22-h continuous infusion) on days 1 and 2. FOLFIRI-2 consisted of irinotecan (180 mg/m2 in a 2-h infusion) on day 1, and then leucovorin (400 mg/m2 in a 2-h infusion) and 5-FU (a 400 mg/m2 bolus, followed by 2400 mg/m2 in a 46-h continuous infusion) on day 1.Results
A total of 158 patients were included. The overall response rate was 9.6 % in patients with measurable lesions. The median progression-free survival (PFS) and overall survival (OS) were 2.1 months [95 % confidence interval (CI), 1.7–2.5] and 5.6 months (95 % CI, 4.7–6.5), respectively. The major grade 3/4 toxicity was myelosuppression (36.7 %). Good performance status (PS), fewer metastatic sites, and longer duration from the first-line to third-line chemotherapy were independent prognostic factors affecting both PFS and OS.Conclusions
The FOLFIRI regimen showed antitumor activity and tolerable toxicity profiles against advanced GC in the third-line setting. Patients with good PS, fewer metastatic sites and longer previous treatment duration might have the maximal benefit from third-line chemotherapy. 相似文献12.
Fischer von Weikersthal L Schalhorn A Stauch M Quietzsch D Maubach PA Lambertz H Oruzio D Schlag R Weigang-Köhler K Vehling-Kaiser U Schulze M Truckenbrodt J Goebeler M Mittermüller J Bosse D Szukics B Grundeis M Zwingers T Giessen C Heinemann V 《European journal of cancer (Oxford, England : 1990)》2011,47(2):206-214
Purpose
To determine whether irinotecan plus oxaliplatin (mIROX) is superior to irinotecan plus infusional 5-fluorouracil, leucovorin (FUFIRI) as first-line therapy of patients with metastatic colorectal cancer (mCRC).Patients and methods
A phase III, randomised, open-label multicentre study compared standard treatment with FUFIRI (irinotecan 80 mg/m2, 5-fluorouracil 2000 mg/m2, folinic acid 500 mg/m2 weekly times 6) to mIROX using an identical schedule of irinotecan plus oxaliplatin 85 mg/m2 applied on days 1, 15 and 29 of a 7-week cycle. The primary end-point was progression-free survival (PFS).Results
A total of 479 eligible patients were randomly assigned. Progression-free survival was 7.2 months in the mIROX arm and 8.2 months in the FUFIRI arm [hazard ratio = 1.14; 95% confidence interval (CI) 0.94-1.37; P = 0.178]. Comparable results were also obtained for overall survival time with 19 months in the mIROX-arm and 22 months in the FUFIRI-arm (hazard ratio = 1.08, P = 0.276). Both regimens induced an identical objective response rate (ORR) of 41%, but disease control rate (ORR plus stable disease) was significantly greater in the FUFIRI group (81% versus 68%, P = 0.001). Most frequent grades 1-4 side-effects of mIROX and FUFIRI treatment were nausea (80% versus 73%) and delayed diarrhoea (79% versus 68%). Grades 3-4 toxicities were generally below 10%, except for diarrhoea which was more frequent in the mIROX-arm compared to the FUFIRI-arm (19% versus 30%, P = 0.006)Conclusion
mIROX failed to show superior activity compared to high-dose 5-FU/folinic acid plus irinotecan. Due to better tolerability the combination of high-dose 5-FU/folinic acid and irinotecan remains a standard of care in first-line treatment of metastatic colorectal cancer. 相似文献13.
Koizumi W Nakayama N Tanabe S Sasaki T Higuchi K Nishimura K Takagi S Azuma M Ae T Ishido K Nakatani K Naruke A Katada C 《Cancer chemotherapy and pharmacology》2012,69(2):407-413
Purpose
We conducted a phase II study to evaluate the efficacy and safety of a triplet regimen of docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer.Methods
Docetaxel (40?mg/m2) and cisplatin (70 or 60?mg/m2) were given on day 1 of a 28-day cycle. S-1 (40?mg/m2) was given twice daily on days 1?C14. Treatment with this regimen was continued for a maximum of 6 cycles. Subsequently, patients with no disease progression received a combination of docetaxel and S-1.Results
Fifty-nine patients were enrolled. The median number of administered cycles was 8 (range, 1?C25). Because some patients had serious myelosuppression and renal dysfunction with 70?mg/m2 of cisplatin, dose of cisplatin was reduced to 60?mg/m2 after 19 patients had been treated. Common severe toxic effects of grade 3 or 4 were leukocytopenia (44%), neutropenia (72%), anemia (15%), and febrile neutropenia (14%). The overall response rate of this group was 81% (95% confidence interval (CI), 71?C91%). The median overall survival and progression-free survival were 18.5 (95% CI, 15.6?C21.5) and 8.7 (95% CI, 6.7?C10.7) months, respectively.Conclusions
Triplet of docetaxel, cisplatin, and S-1 is a well-tolerated and highly active regimen for advanced or recurrent gastric cancer. A 60?mg/m2 of cisplatin is as effective as 70?mg/m2 of cisplatin. 相似文献14.
Boukovinas I Androulakis N Kentepozidis N Polyzos A Papakotoulas P Ziras N Kotsakis A Vardakis N Karampeazis A Markos V Kostakopoulos A Constantinides CA Samonis G Mavroudis D Georgoulias V 《Cancer chemotherapy and pharmacology》2012,69(2):351-356
Purpose
To assess the antitumor activity and toxicity of gemcitabine, cisplatin, and docetaxel (GCD) regimen in patients with locally advanced or metastatic urothelial cancer.Patient and methods
Chemotherapy-na?ve patients, aged ??70?years with measurable or evaluable disease and a performance status (PS) of 0?C2 were treated with sequential cisplatin 80?mg/m2 (d1), gemcitabine 1,100?mg/m2 (d1 and d14), and docetaxel 80?mg/m2 (d14) every 28?days.Results
Sixty patients with an ECOG PS of 0?C2 were enroled. Most (71.7%) patients had stage IV disease. A median number of 4 chemotherapy cycles per patient (range, 1?C9) was administered. Eight (13.3%) patients achieved a CR and 16 (26.7%) a partial response (PR) (intention-to-treat: ORR 40%; 95% CI 27.6?C52.4%). Thirteen (21.7%) and 23 (38.3%) patients experienced stable and progressive disease, respectively. The median time to progression (TTP) was 7.7?months (range, 0.7?C43.4), and the median overall survival 21.4?months (range, 0.7?C68.6). Grade 3 and 4 neutropenia occurred in 27 (45%) patients and grade 3 and 4 thrombocytopenia in five (8.3%). Three (5%) patients developed febrile neutropenia. There were no treatment-related deaths. Severe non-haematological toxicity was infrequent.Conclusions
The GCD combination is an active and well-tolerated regimen in patients with chemotherapy-naive locally advanced or metastatic TCC and merits to be further investigated. 相似文献15.
Weijing Sun James M. Metz Maryann Gallagher Peter J. O��Dwyer Bruce Giantonio Richard Whittington Daniel G. Haller 《Cancer chemotherapy and pharmacology》2011,67(3):621-627
Purpose
Multimodality therapy with chemotherapy and radiation treatment may improve disease control and overall outcome of locally advanced upper gastrointestinal (UGI) malignancies including esophageal, gastric, pancreatic, and biliary tract carcinomas. However, more effective and less toxic chemotherapy regimens with concomitant radiotherapy are needed beyond concurrent continuous-infusion fluorouracil (CIFU) with radiation that is commonly applied in general practice. Epirubicin, cisplatin, and irinotecan are active cytotoxic chemotherapy agents in UGI cancers.Methods
Two parallel phase I studies were designed to test the tolerability (dose-limited toxicity [DLT] and maximum tolerable dose [MTD]) of the combination of radiotherapy concurrently with CIFU, epirubicin, and cisplatin (ECF/radiation) or CIFU, epirubicin, and irinotecan (EIF/radiation) in the treatment of locally advanced upper GI malignancies. CIFU was administered through a portable infusion pump for 5 1/2?weeks during radiation treatment (50.4?Gy?Ca dose of 45?Gy in 25 fractions of 1.8?Gy, with additional comedown of 5.4?Gy). Epirubicin, cisplatin, or irinotecan were administered intravenously each week for 5?weeks (days 1, 8, 15, 22, and 29).Results
The MTDs recommended for further studies are: 5-fluorouracil 200?mg/m2/day CI, weekly cisplatin 20?mg/m2 and epirubicin 10?mg/m2 for ECF/radiation combination; 5-fluorouracil 200?mg/m2/day CI, weekly irinotecan 30?mg/m2 and epirubicin 10?mg/m2 for EIF/radiation regimen. The DLTs are neutropenia, diarrhea/dehydration, and mucositis as expected.Conclusions
Both regimens are safe with expected toxicities, and the efficacy of both regimens was encouraging. Further larger scale studies should be considered. 相似文献16.
Tsuruta H Inoue T Narita S Horikawa Y Saito M Obara T Numakura K Maita S Satoh S Tsuchiya N Habuchi T 《International journal of clinical oncology / Japan Society of Clinical Oncology》2011,16(5):533-538
Background
To evaluate the efficacy and toxicity of a combination chemotherapy consisting of gemcitabine, carboplatin, and docetaxel (GCD) in patients with advanced urothelial carcinoma (UC) as a phase II trial.Materials and methods
Patients with metastatic or locally advanced unresectable UC were eligible for this trial. All enrolled patients were considered to be “unfit??for cisplatin-based chemotherapy, or to have methotrexate, vinblastine, doxorubicin, cisplatin (MVAC)-refractory UC. The chemotherapy regimen consisted of gemcitabine 1000?mg/m2 on days 1 and 8, and carboplatin (with a target area under the curve of 5) and docetaxel 70?mg/m2 on day 1; this was repeated every 21?days.Results
Thirty-five patients were enrolled, with a median age of 68?years. A total of 89 cycles were administered (median, 2 cycles). Major toxicities were Grade 3/4 neutropenia in 28 (80.0%) patients and Grade 3/4 thrombocytopenia in 18 (51.5%). An objective response rate (ORR) was 11 of 21 patients (52.4%), including a complete response in 1 (4.8%). The median overall survival (OS) was 13.1?months (1-year survival rate, 60%) and the median progression-free survival (PFS) was 5.0?months. Among 16 patients who had previously received MVAC, the ORR, the median PFS, the median OS and 1-year survival rate was 56.3%, 5.0?months, 12.6?months and 54%, respectively.Conclusions
GCD chemotherapy is active and well tolerated as a first- or second-line therapy for patients with advanced UC. Response rate, duration and survival did not differ between those with and without a history of MVAC treatment. 相似文献17.
Chengrun Du Hongmei Ying Junjun Zhou Chaosu Hu Youwang Zhang 《International journal of clinical oncology / Japan Society of Clinical Oncology》2013,18(3):464-471
Background
Our aim was to evaluate the efficacy and toxicity of cisplatin, fluorouracil, and docetaxel chemotherapy plus intensity-modulated radiotherapy (IMRT) for locoregionally advanced nasopharyngeal carcinoma (NPC).Methods
Sixty patients with locoregionally advanced NPC were enrolled. Patients received IMRT plus three courses of neoadjuvant chemotherapy and two courses of adjuvant chemotherapy consisting of docetaxel (60 mg/m2/day on day 1), cisplatin (25 mg/m2/day on days 1–3), and 5-fluorouracil (500 mg/m2/day on days 1–3).Results
The overall response rate to neoadjuvant chemotherapy was 89 %. Three months after the completion of radiotherapy, 53 (93 %) patients achieved complete regression, 3 (5 %) achieved partial response (PR), and 1 experienced liver metastasis. However, among the 3 PR patients, 2 patients had no evidence of relapse in the follow-up. With a median follow-up of 27 months (range, 6–43), the 2-year estimated locoregional failure-free survival, distant failure-free survival, progression-free survival, and overall survival were 96.6, 93.3, 89.9, and 98.3 %, respectively. Leukopenia was the main adverse effect in chemotherapy; 14 patients experienced grade 3 or grade 4 neutropenia, and 1 patient developed febrile neutropenia. The nonhematological adverse events included alopecia, nausea, vomiting, anorexia, and diarrhea. The incidence of grade 3 acute radiotherapy-related mucositis was 28.3 %; no grade 4 acute mucositis was observed. No grade 3 or grade 4 hematological toxicity occurred during radiotherapy. None of the patients had interrupted radiotherapy. The common late adverse effects included xerostomia and hearing impairment.Conclusions
Neoadjuvant–adjuvant chemotherapy using cisplatin, fluorouracil, plus docetaxel combined with IMRT was an effective and well-tolerated alternative for advanced NPC. 相似文献18.
Tatsuro Yamaguchi Hiroshi Matsumoto Michiya Yasutome Takeo Mori Keiichi Takahashi 《Cancer chemotherapy and pharmacology》2011,67(3):629-635
Purpose
To evaluate the efficacy and tolerability of systemic chemotherapy with irinotecan (CPT-11), UFT and leucovorin (LV) combined with hepatic arterial infusion (HAI) consisting of 5-fluorouracil (5-FU) in colorectal cancer patients with unresectable liver metastases.Methods
Patients were treated concurrently with escalating doses of intravenous CPT-11 (100, 120, and 140?mg/m2) on day 1 of each 14-day treatment cycle, with oral UFT (300?mg/m2 per day) and LV (75?mg/body per day) on days 1?C7 of each cycle, and with HAI 5-FU (2,000?mg/week) on days 8?C14 of each cycle.Results
Twelve patients were enrolled in the phase I study. The maximum-tolerated dose was not reached. Consequently, the recommended dose of CPT-11 for the phase II study was determined to be 140?mg/m2. Twenty-two patients were evaluated in the phase II study. Five patients experienced grade 3 neutropenia, two experienced grade 3 anorexia, two experienced nausea, and two experienced vomiting. An overall response was observed in 19 out of 22 patients (86.4%). The median progression-free survival period was 11.2?months, and the 3-year survival rate was 50.6%. Fourteen patients (63.6%) were ultimately able to undergo a complete liver resection.Conclusions
Chemotherapy with CPT-11 and UFT/LV combined with HAI yielded a high response rate and enabled a significant proportion of patients with initially unresectable liver metastases to undergo surgical resection. Further trials are warranted. 相似文献19.
Ourania Katopodis Aris Polyzos Nikolaos Kentepozidis Stylianos Giassas Maria Rovithi Vasiliki Bozionelou Kostas Kalbakis Lambros Vamvakas Dimitris Mavroudis Vassilis Georgoulias 《Cancer chemotherapy and pharmacology》2011,67(2):361-368
Purpose
To investigate the efficacy and toxicity of the docetaxel and capecitabine combination in patients with previously treated, unresectable adenocarcinoma of the pancreas.Patients and Methods
Patients with pancreatic adenocarcinoma, pre-treated with gemcitabine-based chemotherapy, were treated with capecitabine (800?mg/m2 orally, twice a day for 14?days) and docetaxel (75?mg/m2 i.v, on day1), every 3?weeks. The primary end-point was overall response rate (RR).Results
Thirty-one patients were enrolled in the study; 93.6% of them had a performance status (PS) of 0?C1 and 96.8% had stage IV disease. Patients received a median of 4 cycles/patient, and the main reason for treatment discontinuation was disease progression. Partial response was observed in three (9.7%) patients, stable disease in seven (22.6%) (disease control rate: 32.3%, 95% CI: 15.80?C48.71%) and disease progression in 21 (67.6%). The median progression-free survival (PFS) was 2.4?months (95% CI: 1.6?C3.13) and the median overall survival (OS) was 6.3?months (95% CI: 3.38?C9.23); the estimated 1-year survival rate was 14.7%. Grade III/IV neutropenia occurred in 10 (32.2%) patients and febrile neutropenia in one patient. Other severe non-hematologic toxicities were mild and manageable. After 2 chemotherapy cycles, pain control occurred in 20% of patients and stabilization of body weight in 40%.Conclusion
The combination of docetaxel/capecitabine may confer good disease control associated with improvement of quality of life as second-line chemotherapy in patients with metastatic pancreatic cancer. 相似文献20.
Carles Pericay Pijaume Pilar Escudero Emperador Román Bastús Piulats Juan Manuel Campos Cervera Gaspar Esquerdo Galiana Manuel Gallén Castillo Jordi Alfaro Gamero Emma Dotor Navarro Aleydis Pisa Gatell Inmaculada Guasch Jordán Eugeni Saigí Grau 《Clinical & translational oncology》2011,13(1):61-66