14 research outputs found
Evaluation of the paclitaxel–ifosfamide–cisplatin (TIP) combination in relapsed and/or metastatic cervical cancer
Treatment of renal cell carcinoma with escalating doses of alpha-interferon
Forty-one patients with advanced renal cell cancer started treatment with recombinant alpha-interferon intramuscularly, beginning at a dose of 5 x 106 U x 3/week, progressively increasing doses every week, from 5 x 106 U x 3/week to 10 x 106 U x 3/ week, to the highest dose of 15 x 106 U x 3/week. No complete response was achieved, partial response was achieved in 6 (13%) patients with a median duration of 45.2 (13-134) weeks. The majority of side effects from interferon treatment evaluated according to WHO classification were seen during the first 2 months and they were fever (after interferon administration) in 95% patients, chills (51%), flu like syndrome (65%), fatigue (87%), anorexia (80%), worsening in performance status (56%), nausea and vomiting (19%), weight loss (> 10% during therapy) (26%), leukopenia (14%), anemia (75%), neurological symptoms (43%), psychological symptoms (19%) and dyspnea (9%). The results are similar to other studies and toxicity was only moderate
Comparison of two oral regimens for the outpatient treatment of low-risk cancer patients with chemotherapy-induced neutropenia and fever: Ciprofloxacin plus cefuroxime axetil versus ciprofloxacin plus amoxicillin/clavulanate
The objective of this investigation was to assess retrospectively the safety and the efficacy of oral ciprofloxacin plus cefuroxime axetil compared to the combination of oral ciprofloxacin plus amoxicillin/ clavulanate, as initial outpatient treatment, in low-risk cancer patients with fever and neutropenia. We analysed retrospectively 120 episodes of febrile neutropenia, treated on an outpatient basis at 2 different oncology units; 63 episodes were treated with the oral regimen of ciprofloxacin plus amoxicillin/clavulanate and 57 were treated with the combination of oral ciprofloxacin plus cefuroxime. 20 treatment failures were recorded-2 of them among patients receiving ciprofloxacin plus amoxicillin/clavulanate and 18 in the ciprofloxacin plus cefuroxime group. Univariate analysis showed that the administration of ciprofloxacin plus cefuroxime was associated with a worse outcome compared to the regimen ciprofloxacin plus amoxicillin/clavulanate (OR 11, CI 2.42-49.9, p = 0.002). In the multivariate model, after adjusting for the absolute number of neutrophils and the duration of neutropenia, the effect of the antibiotic regimen on the outcome disappeared, and no significant differences between the 2 regimens were noted, although the regimen of ciprofloxacin plus cefuroxime was associated with a trend to a worse outcome (OR 4.74, CI 0.72-31.1, p = 0.10). In conclusion, the 2 regimens appeared equally safe and effective but prospective studies are needed to confirm these results
Docetaxel-ifosfamide combination in patients with advanced breast cancer failing prior AnthracyclineBased regimens: Results of a phase I-II study
The established clinical activity of docetaxel and ifosfamide as single
agents in anthracycline pre-treated breast cancer, led us to conduct a
phase I-II study to define the maximum tolerated dose (MTD),
dose-limiting toxicities (DLTs), and clinical activity of the
docetaxel+ifosfamide combination in this setting. Patients with
histologically confirmed metastatic breast cancer, after failure on
prior anthracycline-based chemotherapy, were treated at successive dose
levels (DLs) in cohorts of 3-6 with escalated doses of docetaxel 70-100
mg/m(2) over 1 h on day 1 followed by ifosfamide 5-6 g/m(2) divided over
days 1+2 (2.5-3.0 g/m(2) /day over 1 h), every 21 days. G-CSF was added
once dose-limiting neutropenia was encountered at a certain DL and
planned to be incorporated prophylactically in subsequent higher DLs.
Between March 1997 and December 2002, 65 patients with a median age of
57 years (range, 32-72) and performance status (WHO) of 1 (range, 0-2)
were treated at 5 DLs as follows; 21 in phase I DLs (DL1: 3, DL2: 6,
DL3: 3, DL4: 6, and DL5: 3) and the remaining 44 were treated at DL4
(total of 50 patients at DL4), which was defined as the level for phase
II testing. All patients were assessable for toxicity and 62 for
response. DLT (with the addition of G-CSF after DL2) was reached at DL5
with 2/3 initial patients developing febrile neutropenia. Clinical
response rates (RRs), on an intention-to-treat basis, in phase II were:
56%; (95% CI, 42.2-69.7%); 4 CRs, 24 PRs, 10 SD and 12 PD. The median
response duration was 7 mo (3-24 mo), median TTP 6.5 mo (0.1-26 mo), and
median OS 13 mo (0.1-33 mo). Grade 3/4 toxicities included: neutropenia
in 72% of patients, with 60% developing grade 4 neutropenia (<= 7
days) and in 10% of these febrile neutropenia, while no grade 3/4
thrombocytopenia was observed. Other toxicities included peripheral
neuropathy grade 2 only in 10%, grade 1/2 reversible CNS toxicity in
16%, no renal toxicity, grade 2 myalgias in 8%, grade 3 diarrhea in
8%, skin/nail toxicity in 14%, and grade 2 fluid retention in 2% of
patients. One patient in the study treated at phase II died as a result
of acute liver failure after the first cycle.
The present phase I-II study has determined the feasibility, defined the
MTD and demonstrated the encouraging activity of the
docetaxel-ifosfamide combination in the phase II part of the study.
Therefore, future randomized phase III studies versus single-agent
docetaxel or combinations of the latter with other active agents are
warranted
A pilot evaluation of HER2/neu status between primary breast cancer and metastatic sites developed during trastuzumab-based therapy in patients with metastatic breast cancer (MBC)
A phase II study of the docetaxel-ifosfamide-carboplatin combination in advanced non-small-cell lung cancer
Purpose: In the present phase II study we evaluated the
docetaxel-ifosfamide-carboplatin (DICb) combination in the outpatient
setting in patients with advanced non-small-cell lung cancer (NSCLC).
Patients and Methods: Patients with advanced NSCLC ( stages IIIB/IV),
WHO performance status ( PS) ! 2, and no prior chemotherapy were
eligible. Chemotherapy drug doses were: docetaxel: 80 mg/m(2),
ifosfamide: 3.5 g/m(2), and carboplatin at a target area under the curve
of 5 ( based on Calvert’s formula), all on day 1, followed by
prophylactic G-CSF. Results: Fourty patients were entered and all are
evaluable for response and toxicity: median age: 64 ( 48 - 72); PS: 1 (
0 - 1); gender: 29 males/11 females; stages: IIIB: 13 (33%), IV: 27
(67%). Metastatic sites at diagnosis included: lymph nodes: 25; bone:
7; liver: 4; brain: 5; lung nodules: 13; adrenals: 6. Responses were as
follows: 22/ 40 [55%; 95% confidence interval (CI), 54 - 81%]
evaluable patients responded: 4 complete responses, 18 partial
responses, 11 had stable disease, and 7 had progressive disease. The
median response duration was 7 months ( range 2 14 months), median time
to progression 9 months ( range 2 - 18 months) and median overall
survival 11 months ( range 3 - 46+ months). 1-year survival was 47.5%.
Grade 3/4 toxicities included: neutropenia 28/40, with 12 developing
grade 4 and 12% febrile neutropenia, thrombocytopenia grade 3: 3/40 and
grade 4: 1/40, no grade 3 neuropathy, grade 1 CNS toxicity in 3, no
renal toxicity, 8 grade 2 diarrhea and 4 grade 3 vomiting. Conclusion:
In the present phase II study the DICb combination yielded important
activity and good tolerability in advanced NSCLC. Copyright (C) 2005 S.
Karger AG, Basel
Temozolomide in combination with docetaxel in patients with advanced melanoma: A phase II study of the Hellenic Cooperative Oncology Group
Purpose: Temozolomide is a novel oral alkylating agent that is effective
against melanoma. Moreover, temozolomide readily crosses the blood-brain
barrier and may consequently be effective in patients with brain
metastases. This phase 11 study was performed to assess the efficacy and
safety of the combination regimen of temozolomide and docetaxel in
patients with advanced metastatic melanoma. Patients and
Methods: Sixty-five patients with metastatic melanoma were enrolled.
Treatment consisted of intravenous docetaxel (80 mg/m(2)) on day 1 and
oral temozolomide (150 mg/m(2)) on days 1 to 5, every 4 weeks, for a
maximum of six cycles.
Results: Sixty-two patients were eligible for the efficacy and safety
analysis. Seventeen patients (27%) achieved an objective response,
including five complete (8%) and 12 partial responses (19%). Median
response duration was 9.5 months. Among responders, median time to
progression (TTP) was 11.2 months and median overall survival (OS) was
16 months. For all treated patients, the median TTP was 4 months and
median OS was 11 months. Three (38%) of eight patients who presented
with brain metastases had a partial response for 5, 6, and 12 months. Of
52 patients who did not have brain involvement at presentation, only
four (8%) developed brain metastases at a median follow-up of 14
months. Myelosuppression was the primary toxicity.
Conclusion: The combination of temozolomide and docetaxel was effective
and well tolerated as first-line treatment for patients with advanced
metastatic melanoma and demonstrated encouraging antitumor activity
against brain metastases. (C) 2002 by American Society of Clinical
Oncology
Successful autologous hematopoietic stem cell (AHSC) mobilization with salvage etoposide (VP16)-ifosfamide-platinum (VIP) followed by high-dose chemotherapy (HDC) and AHSC transplantation (AHSCT) in relapsed malignancies: preliminary single center experience.
Paclitaxel (T), ifosfamide (I), and carboplatin (Cb) (TICb) combination chemotherapy in advanced uterine and adnexal malignant mixed mullerian tumors (MMMTs)
Evaluation of the paclitaxel-ifosfamide-cisplatin (TIP) combination in relapsed and/or metastatic cervical cancer
BACKGROUND: Recurrent or metastatic cervical cancer represents an
aggressive malignancy with a high rate of locoregional and distant
failure. Therefore, we evaluated the three-drug combination of
paclitaxel-ifosfamide-cisplatin ( TIP).
METHODS: Systemic chemotherapy-naive patients with advanced
metastatic/relapsed cervical cancer and a World Health Organization (
WHO) performance status ( PS) of 0-2 were eligible. TIP chemotherapy
doses were paclitaxel 175 mg m(-2) on day 1, ifosfamide 2.5 g m(-2) on
days 1 + 2, and cisplatin 40 mg m(-2) on days 1+2, with prophylactic
granulocyte-colony stimulating factor.
RESULTS: A total of 42 patients with recurrent/metastatic cervical
cancer are evaluable for response and toxicity: median age: 56 (25-74)
years; PS: 1 (0-2); histologies-squamous: 35, adenosquamous: 5, and
adenocarcinoma: 2. Responses were overall response rate (RR): 62% (95%
confidence interval (CI): 47.3-76.7%), with complete response (CR):
26% ( 95% CI: 12.7-39.3%), and partial response (PR): 36% ( 95% CI:
21.5-49.9%). Responses according to the relapse site were overall RR:
32% ( 95% CI: 13.7-50.3%) within previously irradiated pelvis vs 75%
(95% CI: 57.7-92.3%) in extra-pelvic sites. Median time to progression
(TTP) was 7 (range, 2-34+) months and median overall survival (OS) was
16.5 (range, 3-36+) months. Toxicities included grade 3-4 neutropenia:
83% (21% febrile neutropenia), grade 3-4 thrombocytopenia: 9%, no
grade 3 neuropathy (35% grade 2), grade 2 asthenia/fatigue 15%, and no
treatment-related deaths.
CONCLUSION: TIP is an active regimen with acceptable toxicity in
advanced/ relapsed cervical cancer. British Journal of Cancer ( 2009)
101, 1059-1065. doi:10.1038/sj.bjc.6605305 www.bjcancer.com Published
online 8 September 2009 (C) 2009 Cancer Research U