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1.
Efficacy and Tolerability of Weekly Docetaxel,Cisplatin, and 5-Fluorouracil for Locally Advanced or Metastatic Gastric Cancer Patients with ECOG Performance Scores of 1 and 2
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《Asian Pacific journal of cancer prevention》2015,16(3):985-989
Background: Docetaxel, cisplatin, 5-fluorouracil (DCF) given every three weeks is an effective, but palliativeregimen and significantly toxic especially in patients who have a low performance score. Here, we aimed to evaluatethe efficacy and tolerability of a weekly formulation of DCF in locally advanced and metastatic gastric cancerpatients. Materials and Methods: 64 gastric cancer patients (13 locally advanced and 51 metastatic) whose ECOG(Eastern Cooperative Oncology Group) performance status (PS) was 1-2 and who were treated with at least twocycles of weekly DCF protocol as first-line treatment were included retrospectively. The weekly DCF protocolincluded 25mg/m2 docetaxel, 25mg/m2 cisplatin, and 24 hours infusion of 750mg/m2 5-fluorouracil, repeated everyweek. Disease and patient characteristics, prognostic factors, treatment response, grade 3-4 toxicity related totreatment, progression free survival (PFS) and overall survival (OS) were evaluated. Results: Of the patients, 41were male and 23 were female; the median age was 63 (29-82) years. Forty-one patients were ECOG-1 and 23were ECOG-2. Of the total, 81.2% received at least three cycles of chemotherapy. Partial response was observedin 28.1% and stabilization in 29.7%. Overall, the disease was controlled in 57.8% whereas progression was notedin 42.2%. The median time to progression was 4 months (95%CI, 2.8-5.2 months) and median overall survivalwas 12 months (95%CI, 9.2-14.8 months). The evaluation of patients for grade 3-4 toxicity revealed that 10.9%had anemia, 7.8% had thrombocytopenia and 10.9% had neutropenia. Non-hematologic toxicity included renaltoxicity (7.8%) and thrombosis (1.6%). Conclusions: In patients with locally advanced or metastatic gastriccancer who were not candidates for DCF administered every-3-weeks, a weekly formulation of DCF demonstratedmodest activity with minimal hematologic toxicity, suggesting that weekly DCF is a reasonable treatment optionfor such patients. 相似文献
2.
Outcome of FOLFOX and Modified DCF Chemotherapy Regimen in Patients with Advanced Gastric Adenocarcinoma
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Mehdi PourghasemianAmin Danandeh MehrMohammad MolaeiAfshin Habibzadeh 《Asian Pacific journal of cancer prevention》2020,21(8):2337-2341
Objectives: Chemotherapy is used as an indispensable therapy for advanced gastric cancer. Different chemotherapy regimens have been used for this purpose. Toxicity due to the Chemotherapy drugs is one limiting factor. In this study we aim to compare the efficacy and toxicity of two regimens FOLFOX (leucoverin, 5-fluorouracil and oxaliplatin) and modified DCF (mDCF) (docetaxel, cisplatin, and 5-fluorouracil) in patients with advanced gastric adenocarcinoma. Methods: In this analytical cross-sectional study, 47 patients treated with FOLFOX regimen and 57 patients treated with mDCF regimen were recruited, Patients in both groups were compared for demographic findings, response rate, mortality rate, overall survival (OS) and progression free survival (PFS). Results: In FOLFOX and mDCF group, complete response (CR) occurred in 4.3% and 5.3%, partial response (PR) in 42.6% and 29.8%, stable disease in 34% and 52.6% and disease progression in 19.1% and 12.3%, respectively (p=0.25). Overall response rate was 48.9% and 56.1%, respectively. There was no significant difference between two regimens in OS and PFS (p=0.22). mDCF compared to FOLFOX had significantly higher hematologic, gastrointestinal complications, as well as creatinine rise, stomatitis and hair loss, but peripheral neuropathy was significantly lower. Conclusion: The results of current study showed that in patients with advanced gastric adenocarcinoma, FOLFOX regimen compared to mDCF regimen have similar ORR, OS and PFS. Toxicity rate are also lower in FOLFOX group, thus it seems a better regimen for chemotherapy. 相似文献
3.
Kunimitsu Kanai Eiji Kikuchi Takashi Ohigashi Akira Miyajima Ken Nakagawa Jun Nakashima Mototsugu Oya 《International journal of clinical oncology / Japan Society of Clinical Oncology》2008,13(6):510-514
Background The objective of this study was to evaluate the efficacy and toxicity of combination chemotherapy with gemcitabine and paclitaxel
as a second-line regimen in patients with advanced urothelial carcinoma.
Methods Twenty patients with advanced urothelial carcinoma who were resistant to an M-VAC (methotrexate, vinblastine, doxorubicin,
and cisplatin) chemotherapy regimen were administered chemotherapy consisting of intravenous gemcitabine 2500 mg/m2 and paclitaxel 150 mg/m2 (GP) every 2 or 3 weeks.
Results The patients received a median of 7.7 cycles of treatment (range, 2–20 cycles). Six of the 20 patients (30%; 95% confidence
interval [CI], 10%–50%) had a major response to treatment (a complete response [CR] in 5% and a partial response [PR] in 25%).
Seven patients (35%) had stable disease (SD). The median duration of response was 4.5 months (range, 1–9 months) and the disease
control rate (CR + PR + SD) was 65%. The median survival was 11.5 months (range, 2–22 months) and the 1-year survival rate
was 35%. The patients tolerated this regimen well, with only grade 3–4 neutropenia being observed in 6 patients (30%), anemia
in 3 (15%), and thrombocytopenia in 1 (5%). The response rate to M-VAC in the first-line chemotherapy was significantly associated
with the response to GP as the second-line chemotherapy.
Conclusion The combination of gemcitabine and paclitaxel is active and well tolerated as a second-line treatment in patients with advanced
urothelial carcinoma. 相似文献
4.
Mori K Kobayashi H Kamiyama Y Kano Y Kodama T 《Cancer chemotherapy and pharmacology》2009,64(1):73-78
Purpose The efficacy and toxicity of combined paclitaxel (PTX) and gemcitabine (GEM) was evaluated as a protocol for first-line chemotherapy
in 40 patients with advanced non-small-cell lung cancer (NSCLC).
Methods Paclitaxel, 100 mg/m2, was administered intravenously (IV) as a 1-h infusion, followed by GEM, 1,000 mg/m2, IV over 30 min on days 1 and 8 of a 21-day cycle. The median age of patients was 66 years with a range of 33–75 years. Nearly
all patients (39/40) had an ECOG performance status of 0 or 1. Thirteen patients (32%) had initial stage IIIB disease and
27 patients (68%) had stage IV disease. Histological subtypes were adenocarcinoma (73%) and squamous cell carcinoma (25%).
Results Twenty-two patients (55%) achieved a partial response and none achieved a complete response, giving an overall response rate
of 55% (95% confidence interval: 38.2–71.8%). Disease stability was achieved in 14 patients (35%), and 4 patients (10%) had
progressive disease. The median survival time was 11.9 months (95% CI: 10.3–14 months), with a 1-year survival rate of 47.5%.
Grade 3 or 4 hematological toxicities observed included neutropenia in 37.5%, anemia in 2.5%, and thrombocytopenia in 5.0%
of these patients. Non-hematologic toxicities were mild, with the exception of grade 3 and 4 pneumonitis. There were no deaths
due to toxicity.
Conclusion Weekly chemotherapy with PTX plus GEM is effective and is acceptable for the first line treatment of advanced NSCLC. 相似文献
5.
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
6.
Feliu J Firvida JL Castro J Madroñal C Rodríguez-Jaráiz A Salgado M Belda-Iniesta C Casado E García-Mata J González-Barón M;Oncopaz Cooperative Group 《Cancer chemotherapy and pharmacology》2009,63(3):403-409
Purpose To determine the efficacy and safety of the combination therapy with docetaxel and cisplatin (CDDP) at low doses in elderly
patients with advanced NSCLC.
Patients and methods A total of 42 patients aged ≥70 years with previously untreated advanced NSCLC received docetaxel 75 mg/m2 plus CDDP 50 mg/m2 on day 1. The regimen was repeated every 21 days. Patients received a minimum of three courses unless progressive disease
was detected.
Results By intent-to-treat analysis, the overall response rate was 31% (95% CI, 17.8–47.2%). A total of 18 patients (43%) had stable
disease and 11 (26%) progressed. Median time to progression was 5.2 months. Overall median survival was 8.9 months, with 1-year
actuarial survival rate of 41%. Eastern Cooperative Oncology Group performance status was improved in 18 patients (43%). The
chemotherapy regimen was well tolerated. A total of 11 patients (26%) had grade 3/4 adverse events: 7 (17%) neutropenia (one
of them was diagnosed with febrile neutropenia), 3 (7%) asthenia, 3 (7%) nausea/vomiting, 1 (2%) diarrhea, 1 (2%) thrombocytopenia
and 1 (2%) neurotoxicity. No death due to toxicity was seen.
Conclusion The combination of low-dose CDDP and docetaxel for elderly patients with advanced NSCLC is an efficient and well-tolerated
chemotherapeutic approach. 相似文献
7.
Takeshi Ishikawa Tomoyo Yasuda Tetsuya Okayama Osamu Dohi Naohisa Yoshida Kazuhiro Kamada Kazuhiko Uchiyama Tomohisa Takagi Hirotaka Konishi Atsushi Shiozaki Hitoshi Fujiwara Hideyuki Konishi Yuji Naito Satoshi Teramukai Yoshito Itoh 《Cancer science》2019,110(12):3754-3760
Preoperative or induction chemotherapy with docetaxel, cisplatin, plus 5‐fluorouracil (DCF) is a promising regimen for advanced esophageal cancer. However, the DCF regimen is associated with a high risk of severe neutropenia or febrile neutropenia (FN). However, the current guidelines fail to recommend an optimal dosing schedule of pegfilgrastim along with the DCF regimen to prevent FN. In the present study, we assessed the efficacy and safety of giving pegfilgrastim early on day 3 during DCF therapy for esophageal cancer. In this single‐arm phase II study, patients with squamous cell carcinoma of the esophagus were recruited. They were treated with the DCF therapy on days 1‐5, with pegfilgrastim given on day 3. Primary endpoint was the occurrence of grade 4 neutropenia. Secondary endpoints included the incidence of FN, grade 3 neutropenia, dose delays/reductions, antitumor effect, and safety. Between July 2016 and December 2018, 23 patients were enrolled. The incidence of grade 4 neutropenia was 8.7% (95% confidence interval 1.1%‐28.0%). No patient experienced FN. Of the 19 patients who received two cycles of DCF, one required a dose reduction/treatment delay due to hematological toxicity in the second treatment cycle. No serious adverse events, considered relevant to pegfilgrastim, were observed. This is the first prospective study that showed an efficacious dosing schedule of pegfilgrastim for preventing hematological toxicity during DCF therapy. The results might be generalized to other similar regimens where continuous infusions of 5‐fluorouracil are used. 相似文献
8.
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
9.
Arimoto T Nakagawa S Oda K Kawana K Yasugi T Taketani Y 《Medical oncology (Northwood, London, England)》2012,29(2):1253-1254
We retrospectively evaluated the efficacy and toxicity of docetaxel and carboplatin in patients with platinum and paclitaxel-pretreated
recurrent ovarian, fallopian tube, and peritoneal cancer. Forty-two women (38 with ovarian cancer, 1 with fallopian tube cancer,
3 with peritoneal cancer) whose cancer had progressed within 12 months of their last treatment with both a platinum agent
and paclitaxel were treated with docetaxel (70 mg/m2, day 1) and carboplatin (area under the curve of 4–6, day 1). Thirty-four patients had measurable disease. The objective
response rate was 23% within 0–6 months of the progression-free interval, 50% within 6–12 months, and 32% (11 of 34 patients)
for both groups. The median time to tumor progression was 28, 49, 34 weeks, and the median overall survival time was 94, 224,
111 weeks, respectively. The most common toxicity was grade 3/4 neutropenia (98% of patients), with 15 episodes (8.4% of courses)
of neutropenic fever. The main nonhematologic toxicity was hypersensitivity; 7 patients (17%) required discontinuation of
the therapy. The results of our study indicate that the combination of docetaxel and carboplatin is effective against recurrent
ovarian, fallopian tube, and peritoneal cancer with progression-free interval of 6–12 months from previous treatment by paclitaxel
and platinum. On the other hand, single-agent chemotherapy would be better than this regimen considering its low response
rate and severe hematological toxicity for patients with progression-free interval less than 6 months. 相似文献
10.
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
11.
Hiroki Hara Makoto Tahara Hiroyuki Daiko Ken Kato Hiroyasu Igaki Shigenori Kadowaki Yoichi Tanaka Yasuo Hamamoto Hisayuki Matsushita Michitaka Nagase Yoshinori Hosoya 《Cancer science》2013,104(11):1455-1460
The combination of docetaxel, cisplatin, and 5‐fluorouracil (DCF) as preoperative treatment for esophageal squamous cell carcinoma (ESCC) has not been investigated. We carried out a multicenter phase II feasibility study of preoperative chemotherapy with DCF for ESCC. Patients with clinical stage II/III ESCC (International Union Against Cancer TNM classification system, 6th edition) were eligible. Chemotherapy consisted of i.v. docetaxel (70–75 mg/m2) and cisplatin (70–75 mg/m2) on day 1, and continuous infusion of fluorouracil (750 mg/m2/day) on days 1–5. Antibiotic prophylaxis on days 5–15 was mandatory. This regimen was repeated every 3 weeks with a maximum of three cycles allowed. After completion of chemotherapy, esophagectomy with extended lymphadenectomy was carried out. The primary endpoint was the completion rate of protocol treatment. Forty‐two eligible patients were enrolled. During chemotherapy, the most common grade 3 or 4 toxicities were neutropenia (83%), anorexia (7%), and stomatitis (5%). Forty‐one (98%) patients underwent surgery. The completion rate of protocol treatment was 90.5% (38/42). No treatment‐related death was observed and the incidence of operative morbidity was tolerable. According to RECIST, the overall response rate after the completion of DCF was 64.3%. Pathological complete response was achieved in 17%. The estimated 2‐year progression‐free survival and overall survival were 74.5% and 88.0%, respectively. Although these data are preliminary, preoperative DCF was well tolerated. Antitumor activity was highly promising and warrants further investigation. This trial was registered with University Hospital Medical Information Network (no. UMIN000002396). 相似文献
12.
Uygun K Aksu G Cicin I Karagol H Kocak Z Fayda M Binici A Uzunoglu F 《Medical oncology (Northwood, London, England)》2008,25(4):408-414
Summary
Background To evaluate the efficiency of docetaxel as second line chemotherapy in patients with platinum-refractory non-small cell lung
carcinoma (NSCLC). Patients and methods Fifty-two patients with locally advanced or metastatic NSCLC who had platinum-refractory disease (progressed through or within
3 months of completion of first line therapy) and an Eastern Cooperative Oncology Group performance (ECOG) status 0–2 were
treated with second-line chemotherapy consisting of single agent docetaxel (100 mg/m2, intravenously, on day 1 of a 21-day cycle). The median number of treatment cycles was 4 (2–6). Disease-free (DFS) and overall
survival (OS), response rates and toxicity were evaluated. Results The median progression-free survival of patients was 3 months (95% CI: 0.01–5.99) and overall survival was 7.2 months (95%
CI: 2.2–9.5). One-year overall survival rate was 29%. Disease control (complete response, partial response, or stable disease)
was achieved in 25 patients (48%) and overall response rate was 13% (7 patients). There were no complete responses. Seventeen
patients (33%) had stable disease and twenty-seven patients (52%) had progressive disease. Age, gender, stage at diagnosis
(IIIB vs. IV), performance status at initiation of second-line therapy (0–1 vs. 2) histopathological type (epidermoid vs.
others), grade, LDH, albumin, weight loss were evaluated as prognostic factors; however, none of these had a significant affect
on survivals. The protocol was well tolerated and there were no toxic deaths. Grade III–IV anemia was present in 8 patients
(15%) and thrombopenia in 12 (23%) patients. The most frequent grade 3–4 toxicities were leucopenia (52%) and neutropenia
(48%). Febril neutropenia occurred in 14 patients (26%). No patients experienced grade III–IV mucositis and diarrhea. Totally,
the need of a dose reduction was about 25% and treatment delay (4–9 days) occurred in 5 patients (10%) and 7 patients (13%),
respectively, because of toxicity. Conclusions Second-line chemotherapy with single-agent docetaxel offers a small but significant survival advantage with acceptable toxicity
for patients with advanced NSCLC who have platinum-refractory disease. 相似文献
13.
Seo HY Kim DS Choi YS Sung HJ Park KH Choi IK Kim SJ Oh SC Seo JH Choi CW Kim BS Shin SW Kim YH Kim JS 《Cancer chemotherapy and pharmacology》2009,63(3):433-439
Purpose We performed a single-institution retrospective study to evaluate the efficacy and toxicities of oxaliplatin, 5-fluorouracil
(5-FU), leucovorin (LV) combination chemotherapy as salvage treatment in patients with metastatic or advanced gastric cancer.
Methods Sixty-two patients with advanced gastric cancer previously treated were eligible for the study. Patients received oxaliplatin
100 mg/m2 and LV 100 mg/m2 (2-h intravenous infusion) followed by 5-FU 2,400 mg/m2 (46-h continuous infusion) every 2 weeks, and responses were assessed after every three cycles.
Results Fifty-nine out of 62 patients were assessable for response. Among them, 46 patients had previously been treated with cisplatin
based chemotherapy. Patients had a median age of 57 years (range 32–76 years), 72.6% had an Eastern Cooperative Oncology Group
performance status of 0 or 1. Total 296 courses of chemotherapy were administered as second-line (67.7%) or third-line (27.4%),
and the median courses per patient was three cycles. Out of 59 evaluable patients, 14 partial responses were observed (overall
response rate, 22.6%). Stable disease was observed in 22 patients (35.5%), and progressive disease in 23 patients (37.1%).
The median response duration, time to progression, and overall survival were 2.3, 3.0, and 8.0 months, respectively. The major
toxicities were neutropenia, mucositis, and peripheral neuropathy. Grade 3 or 4 hematologic toxicities included neutropenia
in nine patients (14.5%) and thrombocytopenia in one patient (1.6%). Other grade 3 or 4 toxicities included mucositis in one
patient (1.6%) and vomiting in two patients (3.2%). Grade 1 or 2 peripheral neuropathy were observed in 18 patients (29.0%),
however there were no cases of grade 3 or 4 peripheral neuropathy and no treatment-related deaths.
Conclusion The combination of oxaliplatin, 5-FU and LV was effective and safe salvage chemotherapy in advanced gastric cancer patients. 相似文献
14.
Scott LC Yao JC Benson AB Thomas AL Falk S Mena RR Picus J Wright J Mulcahy MF Ajani JA Evans TR 《Cancer chemotherapy and pharmacology》2009,63(2):363-370
Purpose Combination chemotherapy results in a significant survival advantage in patients with advanced gastric cancer compared to
best supportive care. Nevertheless, the prognosis remains poor with a median survival of 8–10 months. Topoisomerase-I inhibitors
such as irinotecan have activity in advanced gastric cancer. Pegamotecan may offer significant advantages over other topoisomerase-I
inhibitors due to its prolonged circulating half-life, tolerability and passive tumour accumulation.
Patients and methods This was a non-randomised, multi-centre, two-step Fleming design phase II study. Eligible patients with locally advanced (inoperable)
or metastatic gastric or gastro-oesophageal adenocarcinoma, with measurable disease, ECOG performance status ≤2, with adequate
haematological, renal and hepatic function, who had received ≤1 prior chemotherapy regimen for advanced disease, were treated
with 7,000 mg/m2 of pegamotecan as a 1-h infusion every 21 days until disease progression or unacceptable toxicity. The primary efficacy measure
was the objective response rate.
Results Five of the 35 patients recruited into this study had a partial response (14.3%), with a median time to progression of 11.9 weeks
(95% CI: 6.6, 13.1), and median overall survival of 38.1 weeks (95% CI: 29.0, 47.3). Grade 3/4 toxicities included neutropenia
in 6 (17.1%) patients, thrombocytopenia in 4 (11.4%), fatigue in 8 (22.9%), nausea in 6 (17%), vomiting in 6 (17%) and anorexia
in 4 (11.4%) patients. There were no episodes of febrile neutropenia and no toxic deaths.
Conclusions Pegamotecan has activity in this patient population and was generally well-tolerated. The favourable rate of haematological
toxicities and diarrhoea compared with irinotecan in similar studies suggests that pegamotecan could be combined with other
active agents in further studies in this disease. 相似文献
15.
Phase II study of 5-fluorouracil and paclitaxel in patients with gemcitabine-refractory pancreatic cancer 总被引:1,自引:0,他引:1
Kim YJ Bang S Park JY Park SW Chung JB Song SY 《Cancer chemotherapy and pharmacology》2009,63(3):529-533
Purpose There is no effective salvage regimen for failed gemcitabine-based chemotherapy. This study evaluated the efficacy and toxicity
of 5-fluorouracil and paclitaxel in patients with gemcitabine-refractory pancreatic cancer.
Methods Between January 2004 and December 2007, 28 patients with pancreatic cancer previously treated with gemcitabine-based chemotherapy
were enrolled. 5-Fluorouracil 1,000 mg/m2 was infused (days 1, 2, and 3) and paclitaxel 175 mg/m2 (day 1) was administered every 4 weeks. The primary endpoint of this study was efficacy and toxicity and the secondary endpoint
was time to progression and overall survival.
Results A total of 75 cycles were given, for a mean of 2.68 cycles per patient. The response could be evaluated in 20 patients. Two
patients (10%) obtained a partial response, and four patients (20%) had stable disease. The median time to progression and
overall survival was 2.5 and 7.6 months, respectively.
Grade 3/4 hematological toxicity included neutropenia in six patients (21.4%), anemia in one (3.6%), and thrombocytopenia
in one (3.6%). One (3.6%) patient experienced grade 4 neuropathy, and two (7.2%) patients experienced grade 3 diarrhea.
Conclusion The 5-fluorouracil and paclitaxel combination treatment seems to be effective in patients with advanced pancreatic cancer
that did not respond to a gemcitabine-based regimen. 相似文献
16.
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17.
Phase II study of doxorubicin and cisplatin in patients with metastatic hepatocellular carcinoma 总被引:5,自引:0,他引:5
Lee J Park JO Kim WS Park SH Park KW Choi MS Lee JH Koh KC Paik SW Yoo BC Joh J Kim K Jung CW Park YS Im YH Kang WK Lee MH Park K 《Cancer chemotherapy and pharmacology》2004,54(5):385-390
Objective The outcome of systemic chemotherapy in metastatic hepatocellular carcinoma (HCC) patients had been disappointing. Based on the demonstrated antitumor activities and different mechanisms of action and toxicity profiles, we designed a phase II trial of combination therapy with doxorubicin and cisplatin in metastatic HCC patients anticipating a synergistic interaction of the combination.Methods From January 1998 to January 2003, 42 consecutive patients with metastatic HCC were accrued. The regimen consisted of doxorubicin 60 mg/m2 delivered as an intravenous infusion over 30 min on day 1, followed by cisplatin 60 mg/m2 infused over 1 h on day 1. The cycle was repeated every 28 days. The objective tumor response was evaluated after two or three courses of chemotherapy. The serum alpha-fetoprotein level was measured at the start of every cycle.Results In total, 122 cycles of the regimen were administered, with a median of three cycles per patient (range one to eight cycles). The median age of the patients was 45 years (range 19–61 years), and 37 were evaluable for treatment response. The objective response rate was 18.9% (95% CI 8.0–35%) with one complete response and six partial responses. Six patients (16.2%) had stable disease and 24 patients (64.9%) had progression. Median overall survival of 37 patients was 7.3 months (95% CI 5.9–8.6 months). The median time to progression of all evaluable patients was 6.6 months (95% CI 5.4–7.8 months). Of 37 evaluable patients, 12 32.4%, 95% CI 18.0–49.8%) showed more than 50% decrease in AFP level from their baseline AFP and the median time to decrease in AFP by more than 50% was 1.8 months with a range of 0.7–4.7 months. The chemotherapy was well tolerated and the most common grade 3/4 side effects were neutropenia (14.3%), thrombocytopenia (11.9%), and diarrhea (9.5%).Conclusion Combination chemotherapy with doxorubicin and cisplatin in metastatic HCC patients showed modest antitumor activity with relatively tolerable adverse effects. The objective response rate of the regimen was comparable to those found in other phase II trials, but the search for the optimal chemotherapy should be continued. 相似文献
18.
A Modified Epirubicin and Oxaliplatin Plus Capecitabine (EOX) Regimen as a Second- Line Therapy in Patients with Advanced Gastric Cancer
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Yakup BozkayaNuriye Yıldırım ÖzdemirOzan YaziciNebi Serkan DemirciAlican KurtipekGökmen Umut ErdemYakup ErgünNurullah Zengin 《Asian Pacific journal of cancer prevention》2018,19(1):283-290
Objective: We aimed to evaluate the effectiveness of an mEOX (modified epirubicin, oxaliplatin plus capecitabine) regimen as second line therapy after failure of mDCF (modified docetaxel, cisplatin plus fluorouracil). Methods: Gastic cancer patients for whom first-line therapy was unsuccessful and who subsequently received mEOX (epirubicin 50 mg/ m2 on day 1, oxaliplatin 85 mg/m² day 1 and capecitabine twice-daily dose of 625 mg/ m2, p.o. for 2 weeks) every 3 weeks until disease progression or unacceptable toxicity, were retrospectively analyzed. Results: The study population comprised 129 cases with a median age of 55 years (range= 27-78), the majority being male (76 %). Most (75.2%) had ≥ 2 sites of metastasis. The median number of chemotherapy courses was five (range= 2–9). Forty-nine achieved a partial response and 33 showed stable disease, resulting in a ORR (overall response rate) of 38% and a DCR (disease control rate) of 63.6%. The most frequent features of grade 3-4 hematological and non-hematological toxicity were neutropenia (8.5%) and nausea/vomiting (5.4%). None of the patients suffered death due to toxicity. The median PFS was 4.7 months (95% CI, 4.1–5.3) and the OS was 7.4 months (95% CI, 6.3–8.5). On multivariate analysis, age ≥ 60 years and ECOG performance status (0-1) were independent prognostic factors affecting PFS and OS. Conslusions: In advanced gastric cancer patients, who progress after first line chemotherapy and have an ECOG performance status of 0-1, mEOX is a well tolerated triple regimen associated with a promising OS and PFS. 相似文献
19.
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
20.
Takuji Okusaka Masafumi Ikeda Akira Fukutomi Tatsuya Ioka Junji Furuse Shinichi Ohkawa Hiroyuki Isayama Narikazu Boku 《Cancer science》2014,105(10):1321-1326
The FOLFIRINOX combination of chemotherapy drugs had not been fully evaluated for Japanese pancreatic cancer patients. Therefore, we carried out a phase II study to examine the efficacy and safety of FOLFIRINOX in chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer. FOLFIRINOX (i.v. infusion of 85 mg/m2 oxaliplatin, 180 mg/m2 irinotecan, and 200 mg/m2 l‐leucovorin, followed by a bolus of 400 mg/m2 fluorouracil and a 46‐h continuous infusion of 2400 mg/m2 fluorouracil) was given every 2 weeks. The primary endpoint was the response rate. The 36 enrolled patients received a median of eight (range, 1–25) treatment cycles. The response rate was 38.9% (95% confidence interval [CI], 23.1–56.5); median overall survival, 10.7 months (95% CI, 6.9–13.2); and median progression‐free survival, 5.6 months (95% CI, 3.0–7.8). Major grade 3 or 4 toxicities included neutropenia (77.8%), febrile neutropenia (22.2%), thrombocytopenia (11.1%), anemia (11.1%), anorexia (11.1%), diarrhea (8.3%), nausea (8.3%), elevated alanine aminotransferase levels (8.3%), and peripheral sensory neuropathy (5.6%). Febrile neutropenia occurred only during the first cycle. There were no treatment‐related deaths. FOLFIRINOX can be a standard regimen showing favorable efficacy and acceptable toxicity profile in chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer. 相似文献