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1.
Lee JL Ryu MH Chang HM Kim TW Yook JH Oh ST Kim BS Kim M Chun YJ Lee JS Kang YK 《Cancer chemotherapy and pharmacology》2008,61(4):631-637
Purpose Fluoropyrimidine (F) and platinum (P) combination chemotherapy has been widely used as a first-line treatment of advanced
gastric cancer (AGC). Docetaxel has shown promising activity against this disease. In this study, we explored the efficacy
and safety of docetaxel monotherapy as salvage chemotherapy in AGC after F and P combination chemotherapy failed.
Materials and methods From October 2004 to October 2005, 49 eligible patients were enrolled in this study. The median treatment-free interval was
28.0 days, and 81.6% of patients had suffered cancer progression within 4 months after the withdrawal of first-line chemotherapy.
Docetaxel was given IV at a dose of 75 mg/m2 every 3 weeks, together with dexamethasone prophylaxis.
Results A total of 182 cycles of docetaxel were administered with a median of 3 (range 1–9) cycles. From an intention-to-treat analysis,
eight patients achieved objective response with a response rate of 16.3% (95% CI, 6.0–26.6). The median response duration
was 4.7 months. A total of 20 patients showed stable disease, but 17 patients suffered disease progression. At a median follow-up
duration of 11.3 months for surviving patients (range 6.3–18.8 months), the median time to disease progression was 2.5 months
(95% CI, 2.3–2.7) and the median overall survival time since the start of docetaxel monotherapy was 8.3 months (95% CI, 6.7–9.8).
Grade 3/4 neutropenia and febrile neutropenia occurred in 18.4% of patients and in 5.4% of cycles. The incidence of non-hematologic
toxicities of grade 3 or worse was asthenia 32.7%, diarrhea 10.2% and peripheral sensory neuropathy 8.2%.
Conclusion Docetaxel at 75 mg/m2 is active against AGC as second-line chemotherapy after prior exposure to F and P combination chemotherapy. The toxicity
profile is moderate. 相似文献
2.
Tas F Demir C Camlica H Ustuner Z Topuz E 《Medical oncology (Northwood, London, England)》2004,21(3):233-240
Docetaxel has been the only single active agent against chemotherapy-pretreated non-small-cell lung cancer (NSCLC). The purpose
of this phase II study was to evaluate the efficacy and safety of docetaxel combined with gemcitabine, another effective drug,
in patients with NSCLC previously treated with platinum-based chemotherapy. Thirty-three patients were enrolled. Prior chemotherapy
was cisplatin combined with etoposide in 24 patients and vinorelbine in 9 patients. Tumors were sensitive (n=15), resistant (n=9), and refractory (n=9) to front-line chemotherapy. Treatment was docetaxel 85 mg/m2 on d 1, and gemcitabine 1200 mg/m2 on d 1 and 8, with cycles repeated every three weeks. Ten patients (30.3%, 95% CI: 15.6–48.7) achieved a partial response
and 15 (45.5%) stable disease. Responses were similar frequencies in platinum-sensitive and platinum-resistant/refractory
tumors. With a median follow-up period of 5.7 mo (range 1.6–20.0), the median and 6-mo event-free survival were 5.5 mo, 40.6%,
respectively. Median and 6-mo over-all survival were 7.3 mo and 52.7%. Patients with progressive disease to chemotherapy (p=0.0008), higher LDH (p=0.005), and NSE levels (p=0.03) survived shorter than other patients. In patients refractory to prior chemotherapy, survival was poor as borderline
significantly (p=0.06). The major hematological toxicity was neutropenia. Grade III–IV neutropenia was noted in 14 (42%) patients, with three
episodes of febrile neutropenia in 111 cycles. Docetaxel combined with gemcitabine is an active and safe second-line therapy
for patients with NSCLC. 相似文献
3.
Docetaxel, 5-fluorouracil, and leucovorin as treatment for advanced gastric cancer: results of a phase II study 总被引:4,自引:0,他引:4
Manuel Constenla Ramon Garcia-Arroyo Isabel Lorenzo Nancy Carrete Begoña Campos Patricia Palacios 《Gastric cancer》2002,5(3):0142-0147
Background: Previous studies have shown that the taxane, docetaxel, is effective in treating gastric cancer. The aim of this study was
to assess the efficacy and safety of docetaxel in combination with 5-fluorouracil (5-FU) and leucovorin (LV).
Methods: Thirty patients with histologically proven locally advanced and/or metastatic gastric cancer with WHO performance status
0–2 were enrolled and received either 75 or 100 mg/m2 docetaxel as a 1-h intravenous infusion on day 1 every 28 days. All patients also received 5-FU (1800 mg/m2) plus LV (500 mg/m2), by continuous intravenous infusion over 24 h on days 1, 8, and 15 every 28 days. Chemotherapy was given for at least two
cycles.
Results: Of the 25 evaluable patients, 3 showed a complete response, 4 showed a partial response, and 11 patients had stable disease.
The overall response rate was 28.0% (95% confidence interval [CI], 10.4, 45.6). The median time to progression was 5.9 months
(95% CI, 5.4, 6.5), and the median overall survival was 7.7 months (95% CI, 7.2, 8.3) for the intent-to-treat population.
The most frequent grade III and IV hematological toxicities were neutropenia and anemia. Febrile neutropenia was observed
in 10% of patients and 2.4% of cycles. The prophylactic use of granulocyte colony-stimulating factor (G-CSF) in 3 patients
reduced the incidence and severity of neutropenia. Other hematological toxicities were rare.
Conclusion: Docetaxel in combination with weekly 5-FU and LV is effective in treating patients with advanced/metastatic gastric cancer.
This new docetaxel-containing combination shows promise as a third-generation treatment option for gastric cancer.
Received: December 25, 2001 / Accepted: April 22, 2002
Offprint requests to: M. Constenla 相似文献
4.
Paolo Piacentini Emilia Durante Annarita Trolese Anna Mercanti Andrea Bonetti 《Gastric cancer》2012,15(1):106-110
Abstract
The combination of Taxotere (docetaxel), cisplatin, and prolonged-infusion 5-fluorouracil (5-FU) has emerged as an active treatment for advanced gastric cancer. However, the regimen proposed by van Cutsem et al. (J Clin Oncol 24:4991–7, 2006) is associated with significant toxicity and therefore alternative schedules are needed. In the present study, patients with advanced gastric or esophageal cancer received Taxotere 35 mg/m2 and cisplatin 25 mg/m2 on day 1, followed by 5-FU 180 mg/m2/day as a 7-day prolonged infusion. Drugs were given weekly for 3 consecutive weeks followed by 1 week’s rest. Cycles were repeated every 4 weeks. Overall, a total of 110 cycles were administered to 27 patients (median age 63 years, range 40–78 years). The median number of cycles per patient was 4 (range 2–6). Nine partial responses were obtained, resulting in an overall response rate of 33% [95% confidence interval (CI) 16–51], a median time to progression of 6.4 months (95% CI 5.4–7.4), and a median overall survival of 10.7 months (95% CI 6.6–14.8). Toxicity was mild; grade III-IV neutropenia was the most frequently observed side effect, in 9 administered cycles (8%); neutropenia was complicated by fever in 2 cycles. Other grade III–IV toxicities observed in >5% of patients were anemia and mucositis. 相似文献5.
André M. Murad Nils G. Skare Jéferson Vinholes Sérgio Lago Ricardo Pecego 《Gastric cancer》2006,9(2):99-105
Background This study evaluated the efficacy and safety of docetaxel, epirubicin, and 5-fluorouracil (5-FU) [DEF] as treatment for locally
advanced unresectable or metastatic gastric cancer.
Methods Thirty-seven patients participated in the study (median age, 56 years; range, 22–73 years); Eastern Cooperative Oncology Group
performance status [PS], 0–2). Docetaxel 75 mg/m2 IV (day 1), 5-FU 500 mg/m2 IV (days 1–3), and epirubicin 50 mg/m2 IV (day 1) were administered every 3 weeks for six cycles.
Results In total, 20/37 patients (54%) completed six treatment cycles. Thirteen patients (35%; 95% confidence intervals [CI], 20%
to 51%) had an objective response; 1 patient (3%) achieved a complete response and 12 patients (32%) achieved partial responses.
Stable disease was observed in 7 patients (19%) and progressive disease in 5 patients (14%). Twelve patients (32%) were unevaluable.
Clinical benefit (based on PS, weight gain, and analgesic consumption) was observed in 11 patients (30%). Median follow-up
was 41 months (range, 26–53 months), median time to progression was 6.6 months (range, 0.5–29.2 months), median overall survival
was 10.7 months (range, 7.0–14.6 months), and 1-year survival was 40%. The regimen was well tolerated. Grade 3–4 febrile neutropenia
occurred in 8 patients (22%; 6% of cycles) and grade 3–4 neutropenia in 1 patient (1% of cycles). The most frequent grade
3–4 toxicities were alopecia (11% of cycles), diarrhea (4% of cycles) and vomiting (2% of cycles); grade 1–2 asthenia and
fatigue occurred in 43% of cycles.
Conclusion DEF is effective in the treatment of advanced gastric cancer, and has a good safety profile.
Presented at: 2002 ASCO Meeting (Poster Section): Proc Am Soc Clin Oncol 2002;21:163a and 2002 ESMO Meeting (Poster Section): Ann Oncol 2002;13(Suppl 5):192 相似文献
6.
K. Alexopoulos C. Kouroussis N. Androulakis E. Papadakis M. Vaslamatzis S. Kakolyris G. Samelis E. Patila A. Vossos E. Samantas V. Georgoulias 《Cancer chemotherapy and pharmacology》1999,43(3):257-262
Purpose: To investigate the activity of docetaxel and granulocyte colony-stimulating factor support (G-CSF) in patients with advanced
non-small-cell lung cancer (NSCLC) previously treated with cisplatin. Patients and methods: A total of 60 patients with locoregional and metastatic NSCLC who had relapsed or progressed after first-line treatment
with cisplatin-based regimens were enrolled into the trial. Docetaxel at 100 mg/m2 was given as a 1-h infusion with G-CSF (rhG-CSF given s.c. at 150 μg/m2) support from day 2 to day 8 every 3 weeks; all patients received premedication with corticosteroids. Results: In all, 1 (1.6%) and 14 (23.3%) patients achieved a complete response (CR) and a partial response (PR), respectively, for
an overall response rate of 25% (95% CI 14.0–35.9%); stable disease (SD) and progressive disease (PD) were documented in 18
(30%) and 27 (45%) patients, respectively. The median duration of response was 20 weeks and the median time to tumor progression
was 28 weeks. The median overall survival was 32 weeks and the 1-year survival rate was 23%. A total of 263 courses were given
at a median of 3 cycles/patient. Grade 3 and 4 neutropenia occurred in 11 (18%) and 14 (23%) patients, respectively, with
18 (30%) patients requiring hospitalization for neutropenic fever; 1 patient died of sepsis. Grade 2 peripheral neuropathy
occurred in 9 patients (15%) and grade 3 asthenia, in 4 (7%). Other toxicities were mild. Conclusions: Docetaxel has considerable single-agent activity in patients with NSCLC who have relapsed or progressed after first-line
chemotherapy with cisplatin-based regimens.
Received: 17 June 1998 / Accepted: 17 August 1998 相似文献
7.
Kyoung Ha Kim Young Suk Park Myung Hee Chang Hyo Song Kim Hyun Jung Jun Jieun Uhm Seong Yoon Yi Do Hyoung Lim Sang Hoon Ji Min Jae Park Jeeyun Lee Se Hoon Park Joon Oh Park Ho Yeong Lim Won Ki Kang 《Cancer chemotherapy and pharmacology》2009,64(2):347-353
Purpose We designed this phase I/II study of docetaxel–oxaliplatin combination chemotherapy to determine the dose-limiting toxicity
(DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer.
Methods Patients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels
of oxaliplatin and docetaxel every 3 weeks were tested in a cohort of three patients for each level (respectively, 100 and
60 mg/m2, 100 and 75 mg/m2, 130 and 75 mg/m2). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression,
an unacceptable adverse event, or withdrawal of consent.
Results No DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130 mg/m2 and docetaxel 75 mg/m2 were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall
response rate was 55.3% (95% CI, 40.6–70.1%) and median duration of response was 4.2 months (range 0.9–9.5 months). After
a median follow-up duration of 13.3 months, median overall survival was 12.7 months (95% CI: 10.4–14.9). The median time to
progression was 5.0 months (95% CI, 3.4–6.5 months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%),
neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%).
Conclusion The combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor
activity in unresectable, metastatic gastric cancer patients. 相似文献
8.
Ford HE Yap YS Miles DW Makris A Hall M Miller L Harries M Smith IE Johnston SR 《Cancer chemotherapy and pharmacology》2006,58(6):809-815
Background: Docetaxel has significant activity in metastatic breast cancer and weekly schedules are associated with less myelosuppression than 3-weekly schedules. We evaluated the toxicity and the activity of weekly docetaxel in anthracycline-pretreated patients. Patients and
methods: A total of 42 patients were studied. Treatment consisted of docetaxel 35 mg/m2 weekly as a 30-min infusion for 6 weeks followed by a 2-week rest, with dexamethasone 8 mg i.v. pre-medication and 4 mg orally 12-hourly for 48 h following treatment. Results: The median age of the patients was 53 years (range 34–74). Twenty-six (62%) patients had received prior chemotherapy for advanced disease. Patients received a median 10 weeks of treatment (range 1–24). 11 had a partial response (ORR 26%; 95% CI 13–39%), five of whom had relapsed <12 months since the end of previous anthracycline-based chemotherapy. In addition six patients (14%) had stable disease for >16 weeks. Myelosuppression was rare with only 2 patients (5%) experiencing grade 3 neutropenia (no grade 4 neutropenia). Non-haematological grade III toxicities were as follows: fatigue 17%, neuropathy 0%, hyperlacrimation 5%, stomatitis 7%, diarrhoea 14%, and cutaneous toxicity 19%. Skin toxicity consisted of limb/palmar–plantar erythematous reactions, or fixed-plaque erythrodysaesthesia. Conclusions: Weekly docetaxel has moderate activity in women with anthracycline pre-treated breast cancer. Although the level of myelosuppression is lower than 3-weekly regimens, this weekly regimen cannot be recommended due to the significant non-haematological toxicities associated with the treatment. 相似文献
9.
Katia Lorizzo Nicola Fazio Davide Radice Sabrina Boselli Leonardo Ariu Maria Giulia Zampino Franco Nolè Elena Magni Raffaele Ardito Ida Minchella Andrea Rocca Giovanni Di Meglio Michela Squadroni Filippo de Braud 《Cancer chemotherapy and pharmacology》2009,64(2):301-306
Purpose Second-line chemotherapy in patients with metastatic gastric cancer (MGC) pre-treated with cisplatin is not a standard option.
We studied a combination of irinotecan, fluorouracil and folates.
Methods Patients progressive to cisplatin-based chemotherapy were enrolled. Irinotecan 180 mg/m2, folinic acid 200 mg/m2, and fluorouracil 400 mg/m2 were given on day 1, immediately followed by fluorouracil 2,400 mg/m2 46 h continuous infusion (simplified FOLFIRI), every 2 weeks.
Results Between June 2002 and May 2003, 28 patients were treated. Median age was 57 years (range 38–68). Most patients had a distal
primary (90%), and metastatic disease (71%). Partial response was obtained in six patients (21%, 95% CI 8–41) and stable disease
in eight (21%, 95% CI 13–41). Among the six responsive patients three were refractory to docetaxel. At a median follow-up
of 2.9 years median time to progression was 4 months (95% CI: 2–5), and median overall survival was 5 months (95% CI 4–9).
Toxicity was mild, without treatment-related deaths or life-treating adverse events.
Conclusions Simplified FOLFIRI was moderately active and well tolerated in unselected patients with MGC pre-treated with cisplatin-based
chemotherapy. Its role in patients refractory to taxanes is promising and warrants further investigation. 相似文献
10.
Juan Bayo María Lomas Javier Salvador Alberto Moreno Manuel Ruiz Alberto Rodríguez José Fuentes Ana Fernández-Freire Reyes Bernabé Andrea Fernández 《Clinical & translational oncology》2008,10(12):817-825
Introduction Treatment of HER-2-negative metastatic breast cancer (MBC) patients after anthracycline exposure is controversial. Docetaxel/capecitabine
is a promising regimen, but the administration schedule is not well established.
Materials and methods Treatment included 3 cycles of docetaxel 100 mg/m2 day 1 every 21 days followed by 3 cycles of capecitabine 1250 mg/m2/12 h days 1–14. Patients not progressing were maintained with capecitabine 900 mg/m2/12 h on days 1–14 every 21 days until progression or unacceptable toxicity.
Results Fifty-three anthracycline-pretreated patients were enrolled: median age 54 years, ECOG grade 0–1 86.7%. Most of the women
received adjuvant chemotherapy (81%) and 5 patients (9%) had had prior metastatic chemotherapy treatment. Median time from
anthracycline exposure was 29 months. ORR (intent-to-treatment analysis) after the sequential therapy was 51% (CI 95% 37–65)
with 15% (CI 95% 7–28) of patients reaching complete responses. Median time to progression was 8.2 (CI 95% 7.1–10.7) months,
with 61.9% (CI 95% 45.6–76.4) of the patients free of disease after 6 months. Median overall survival was not reached after
a median follow-up of 10.4 months, and 75% of the patients were alive after 14.3 months. Survival rate after 12 months was
81.1% (CI 95% 68.0–90.6). The most frequent NCI grade 3–4 toxicities were hair loss (28.3%), asthenia (15.1%), stomatitis
(11.32%) and nausea (11.32%). Severe hand-foot syndrome rate was 7.5%.
Conclusions Sequential docetaxel-capecitabine is feasible, effective and well tolerated in first-line MBC treatment. Evaluation of this
schedule in randomised studies is warranted. 相似文献
11.
Casal J Amenedo M Mel JR Antón LM Rodríguez-López R López-López R González-Ageitos A Castellanos J Constenla M Tisaire JL 《Cancer chemotherapy and pharmacology》2007,60(5):725-732
Background Numerous phase II and III clinical trials have demonstrated a higher activity of combined gemcitabine plus docetaxel schedules
against non-small cell lung cancer (NSCLC) than that of both agents in monotherapy.
Methods This phase II study evaluated a 3-week based schedule of docetaxel 85 mg/m2 (1-h i.v. infusion, d8) combined with gemcitabine 1,000 mg/m2 (30-min i.v. infusion; d1,8) as first-line chemotherapy for patients with advanced NSCLC.
Results Forty-one patients with non-resectable, stage IIIB/IV, and bidimensionally measurable disease were enrolled. A total of 182
chemotherapy cycles (median 6, range 1–6) was administered to 40 patients during the study; one patient did not receive chemotherapy
due to a protocol deviation. Two patients were not evaluable for treatment efficacy. The overall response rate found was 44%
(95% CI, 29–59%): three patients (7%) had a complete response and 15 patients (37%) had a partial response (median duration
of response = 4.0 months). With a median follow-up of 8.7 months, the median time to disease progression was 4.4 months and
the median overall survival was 7.3 months. The combined gemcitabine plus docetaxel chemotherapy was well tolerated except
for pulmonary toxicity. The main grade 3–4 hematological toxicity was neutropenia (28% of patients, 9% of cycles). Two cases
of febrile neutropenia were reported. The main grade 3–4 non-hematological toxicity was pulmonary toxicity (23% of patients,
6% of cycles).
Conclusion Gemcitabine 1,000 mg/m2 on days 1 and 8 in combination with docetaxel 85 mg/m2 on day 8 given in 3-week cycles is an active and well-tolerated first-line chemotherapeutic regimen for advanced NSCLC. 相似文献
12.
Sym SJ Chang HM Kang HJ Lee SS Ryu MH Lee JL Kim TW Yook JH Oh ST Kim BS Kang YK 《Cancer chemotherapy and pharmacology》2008,63(1):1-8
Purpose Irinotecan (I) and docetaxel (D), each of which has a unique mechanism of action, were recently introduced in the treatment
of patients with advanced gastric cancer (AGC). We have evaluated the efficacy and safety of the ID combination for AGC patients
after failure of fluoropyrimidine- or platinum-based chemotherapy.
Materials and methods Patients with relapsed or progressive AGC after prior fluoropyrimidine- or platinum-based chemotherapy were treated with I
(160 mg/m2, 90 min) followed by D (65 mg/m2, 1 h) every 3 weeks. Because of the unacceptable toxicity among the first ten patients, the doses were reduced for I (120 mg/m2) and D (50 mg/m2) every 3 weeks.
Results Forty-nine patients, of median age 53 years (range, 27–68 years), were treated with 170 cycles of chemotherapy (median, 2
cycles; range, 1–12 cycles). Three patients achieved complete response and seven achieved partial response, resulting in an
overall response rate (ORR) of 20.4% [95% confidence interval (CI), 9.1–31.7%], with a median duration of 7.1 months (range:
2.1–69.1 months). ORR was 60% (95% CI, 29.6–90.3%) for the higher dose and 10.3% (95% CI, 0.7–19.8%) for the lower dose. Median
time to progression for all patients was 2.7 months (95% CI, 1.7–3.8 months) and the median overall survival was 8.9 months
(95% CI, 6.6–11.3 months). Grade 3/4 toxicities included neutropenia (90%), febrile neutropenia (50%), asthenia (40%), and
diarrhea (10%) with the higher dose and neutropenia (71%), febrile neutropenia (11%), diarrhea (24%), and asthenia (24%) with
the lower dose. There were two possible treatment-related deaths.
Conclusion The combination of irinotecan and docetaxel, once every three weeks shows anti-tumor activity but is not feasible as a second-line
treatment for AGC patients after failure of fluoropyrimidine- or platinum-based chemotherapy due to the high rate of toxicities.
S. J. Sym and H. M. Chang
have contributed equally to this article. 相似文献
13.
Lee J Kim TY Lee MA Ahn MJ Kim HK Lim HY Lee NS Park BJ Kim JS;Korean Cancer Study Group 《Cancer chemotherapy and pharmacology》2008,61(1):47-52
Objectives The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally
advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy.
Methods The treatment consisted of cisplatin 70 mg/m2 in intravenous infusion followed by gemcitabine 1,250 mg/m2 in 30-min intravenous infusion on days 1 and 8, repeated every 3 weeks until disease progression, unacceptable toxicity,
patient’s refusal or up to 8 cycles.
Results Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003. Fourteen patients (40%)
had gall bladder cancer and 20 patients (57%) had cholangiocarcinoma. Thirty-two patients (91%) had metastatic disease at
study entry with liver being the most commonly involved site of metastasis. About 84.5 and 94.2% of the initially planned
dose were administered for gemcitabine and cisplatin, respectively. In the ITT population (n = 35), six partial responses were observed for an objective response rate of 17.1% (95% CI; 4.7–29.6%). Ten patients (28.6%)
had stable disease, 16 (45.7%) progressed, and three (8.6%) were not evaluable. For the 35 patients in the ITT population,
the median overall survival time was 8.6 months (95% CI; 6.1–10.4 months). The median time to disease progression was 3.2 months
(95% CI; 2.3–4.9 months) and the median time to treatment failure was 3.1 months (95% CI; 1.9–4.1 months). Among the six tumor
responders, the median duration of tumor response was 7.3 months (95% CI; 5.6–11.0 months). The most common grade 3/4 maximum
toxicities were nausea (3.4%) and vomiting (2.7%).
Conclusion The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable
toxicity profile.
Supported by Korean Cancer Study Group. 相似文献
14.
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15.
Carlo Barone Michele Basso Giovanni Schinzari Carmelo Pozzo Nunziatina Trigila Ettore D'Argento Michela Quirino Antonio Astone Alessandra Cassano 《Gastric cancer》2007,10(2):104-111
Background In advanced gastric cancer few data are available on the efficacy or safety of new drug combination regimens after progression
following first-line chemotherapy.
Methods Patients with histologically confirmed advanced gastric cancer and Eastern Cooperative Oncology Group (ECOG) performance status
(PS) less than 2, progressing after first-line chemotherapy, were eligible. Patients were treated with docetaxel 75 mg/m2 on day 1 and oxaliplatin 80 mg/m2 on day 2, every 3 weeks, until progression or unacceptable toxicity.
Results Between May 2002 and April 2005, 38 patients were enrolled. Men accounted for 73.7% of the patients and the median age was
59 years. The primary tumor was not resected in 47.4% of the patients; the peritoneum was the most frequent metastatic site
(60.5%). The first-line treatment was cisplatin, epirubicin, and infusional 5-fluorouracil (ECF) in 81.5% of the patients
and cisplatin and infusional 5-fluorouracil (CF) in 15.7%. The median number of cycles was 4.3. The treatment was well tolerated,
with no toxic deaths. National Cancer Institute (NCI) grade III-IV neutropenia was frequent (26.3%), but no febrile neutropenia
was reported. Severe asthenia (15.7%) and severe nausea (15.7%) required dose reductions in 2 patients and treatment discontinuation
in another. The overall response rate was 10.5%, and 18 patients (47.3%) experienced disease stabilization (7 of them with
significant clinical benefit). Median time to progression was 4.0 months (range, 2–8 months) and median overall survival was
8.1 months (range, 3–26 months). Thirteen patients (34.2%) also received third-line chemotherapy, with an irinotecan-containing
regimen, and their median overall survival was higher than that of the other patients (16.3 vs 6.0 months)
Conclusion The combination of oxaliplatin and docetaxel shows only marginal activity as second-line treatment, but it has a good tolerability
profile. This suggests that there is room for optimizing the schedule as well as for planning sequential treatments in gastric
cancer. 相似文献
16.
Application of prolonged microdialysis sampling in carboplatin-treated cancer patients 总被引:1,自引:1,他引:0
Zang DY Yang DH Lee HW Hwang SW Song HH Jung JY Kwon JH Kim HJ Kim JH Park SR Kim MJ Jang KM Park CK Kim JH Lee BH 《Cancer chemotherapy and pharmacology》2009,64(3):509-516
Purpose To determine the dose-limiting toxicity (DLT) and activity of combination with docetaxel and S-1 on unresectable gastric cancer.
Patients and methods Docetaxel was administered intravenously on day 1 and S-1 was administered orally on days 1–14, every 3 weeks. Doses of each
drug in phase I study were docetaxel 60–75 mg/m2 and S-1 60–80 mg/m2. A phase II study was conducted with the recommended dose (RD) based on phase I.
Results Sixty-five patients (median age 54 years) were enrolled. The DLTs were neutropenia with fever or stomatitis. The RD was docetaxel
75 mg/m2 and S-1 60 mg/m2. Two patients (aged 66 and 64 years) developed septic shock during the initial part of phase II study. A phase I study at
lower dose (docetaxel 60 mg/m2 and S-1 80 mg/m2) was conducted for patients older than 60 years, and this dose was determined as the RD for these patients. In the phase
II study, frequent grade 3/4 toxicities were neutropenia (47%) and febrile neutropenia (26%). The overall response rate was
50% (95% CI, 35–66%) and median survival was 15.3 months (95% CI, 10.0–20.6 months).
Conclusions Combination with docetaxel and S-1 was active against advanced gastric cancer and gave manageable toxicities.
Supported in part by a grant from the Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (0412_CR01_0704_0001). 相似文献
17.
Iwasaki Y Ohsugi S Natsuhara A Tsubokura T Harada H Ueda M Arimoto T Hara H Yamada T Takesako T Kohno K Hosogi S Nakanishi M Marunaka Y Nishimura T 《Cancer chemotherapy and pharmacology》2006,58(6):735-741
Objectives: We conducted phase I and II studies of biweekly docetaxel and cisplatin with concurrent radiotherapy, followed by consolidation chemotherapy with the same drugs in patients with locally advanced, unresectable non-small-cell lung cancer (NSCLC). Our objectives were to define the maximum-tolerated dose and dose-limiting toxicity (DLT) in the phase I study, and to determine the response rate, toxicity, and survival rate at the recommended dose (RD) in the phase II study. Methods: Patients with unresectable stage IIIA and IIIB NSCLC were studied. Six to eight cycles of docetaxel and cisplatin were administered at 2-week intervals. In the phase I study, patients received four dose levels: level 1, docetaxel/cisplatin=30/40 mg/m2; level 2, 35/40; level 3, 40/40; and level 4, 45/40. Radiotherapy was delivered at a rate of 2 Gy per fraction/day up to a total dose of 60 Gy over the course of 6 weeks, during the first three cycles of chemotherapy. Results: DLT comprised neutropenia at level 4 in the phase I study (n=15), and level 3 was considered the RD. In the phase II study (n=46), two patients had a complete response (4.3%) and 34 had a partial response (73.9%), for an overall response rate of 78.2% [95% CI (66.3–90.2%)]. The survival rate was 69.1% at 1 year and 39.6% at 2 years, with a median survival time of 19.1 months. Leukopenia, neutropenia, anemia, and radiation esophagitis were the most common toxic reactions, with Grade ≥3 reactions occurring at rates of 77, 70, 17, and 8%, respectively. Conclusion: Biweekly docetaxel and cisplatin with concurrent RT was active and well tolerated in patients with unresectable stage III NSCLC. 相似文献
18.
Han S Kim SB Kang SS Noh WC Paik NS Chang ES Kim JR Lim SH Park HS 《Breast cancer research and treatment》2006,98(1):57-61
SummaryBackground This multicenter phase II study was conducted to evaluate the response and safety of a combination of docetaxel plus doxorubicin as neoadjuvant therapy for stage II, III breast cancer.Methods Patients with stage II or III breast cancer underwent three cycles of neoadjuvant chemotherapy with doxorubicin 50 mg/m2 and docetaxel 75 mg/m2 every 3 weeks followed by curative surgery. Prophylactic GCSF was not used.Results Ninety patients were enrolled in the study and 86 were evaluable for efficacy. The median age was 43 years (range, 30–69). The mean relative dose intensity was 0.98 for docetaxel and 0.98 for doxorubicin. Breast-conserving surgery was performed in 12 (13.7%) patients. The clinical overall response rate was 86% and pathologic complete response was 10.5%. Grade 3/4 neutropenia was observed in 26% of total 258 cycles and febrile neutropenia was observed in 15.8%. Pneumonia was observed in one patient and grade 3 mucositis was observed in three patients.Conclusion Docetaxel and doxorubicin was an effective and well-tolerated neoadjuvant chemotherapy for stage II and III breast cancer. Clinical benefit of this treatment will be confirmed by survival data with long term follow up. 相似文献
19.
Shin SJ Jeung HC Ahn JB Choi HJ Cho BC Rha SY Yoo NC Roh JK Chung HC 《Cancer chemotherapy and pharmacology》2008,61(1):157-165
Purpose The aim of this study was to evaluate the activity and the safety of a combination regimen of capecitabine and doxorubicin
as salvage chemotherapy in advanced gastric cancer patients who had undergone one or two prior chemotherapy regimens.
Methods Patients received capecitabine, 2,500 mg/m2/day PO for 14 days (D1–14) and doxorubicin, 30 mg/m2 IV on day 1 every 3 weeks until disease progression. The response was evaluated according to RECIST criteria, and the toxicity
was evaluated by NCI-CTC (version 2.0).
Results Forty-five patients were enrolled. Twenty-six patients were treated as second-line chemotherapy and the remaining patients
as third-line chemotherapy. A total of 152 cycles of chemotherapy (median 2, range 1–12) were administered. Median dose intensities
of capecitabine and doxorubicin were 11,326 and 9.6 mg/m2/week, respectively. The overall response rate was 6.7% (95% CI, 4.1–12.5%) and the disease control rate was 46.7% (95% CI,
28.6–87.1%) according to an intent-to-treat analysis. The median progression-free survival was 11.3 weeks (95% CI, 5.6–16.7 weeks).
The median overall survival was 29.1 weeks (95% CI, 18.3–39.9 weeks) with one-year survival rate of 24%. Severe (grade III/IV)
hematologic and non-hematologic toxicity was uncommon and included nausea/vomiting in five (11.1%), neutropenia in two (4.4%),
anemia in one (2.2%), and hand-foot syndrome in one patient (2.2%).
Conclusions The combination of capecitabine and doxorubicin is a feasible salvage regimen in advanced pre-treated gastric cancer. 相似文献
20.
Jin Young Kim Young Rok Do Keon Uk Park Min Kyung Kim Kyung Hee Lee Sung Hwa Bae Hun Mo Ryoo Jin Ho Baek Hong Suk Song 《Cancer chemotherapy and pharmacology》2010,66(1):31-36