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PubMed1996

Phase II study of a closely spaced ifosfamide--cisplatin schedule with the addition of G-CSF in advanced non-small-cell lung cancer and malignant melanoma.

BACKGROUND: Ifosfamide and cisplatin are frequently combined cytotoxic agents. Both have a dose-response relationship. In view of this it appears attractive to study regimens with a higher dose intensity than usual. One way to increase the dose intensity is to shorten intervals between chemotherapy cycles. As bone marrow toxicity is dose limiting in ifosfamide-cisplatin combinations we started a phase II study with both drugs administered every 2 weeks in combination with G-CSF. PATIENTS AND METHODS: Patients with advanced non-small-cell lung cancer or malignant melanoma were eligible for the study. The treatment consisted of ifosfamide 2 gram/m2/day days 1-3 combined with mesna, and cisplatin 33 mg/m2/day days 1-3, administered in hypertonic saline (3% NaCl). G-CSF was started on day 4 at a dose of 5 micrograms/kg/day and was continued until day 12. The cycles were to be repeated every 2 weeks for a maximum of 6 cycles. RESULTS: Thirty-two patients were entered in the study; 30 patients were evaluable for response and toxicity. Neutropenia (grade 4 in 16 patients) and thrombocytopenia (grade 4 in 15 patients) were the most common toxicities. Thrombocytopenia incidence and -duration increased per cycle and was the main cause of treatment delays especially after the third cycle. Only 4 patients were able to complete the planned treatment without any delay or dose reduction and reached the intended dose intensity of 3 gram/m2/week of ifosfamide and 50 mg/m2/week of cisplatin. Non haematologic toxicities were generally mild. Out of 22 evaluable patients with non-small cell lung cancer 6 responded (27%; 95% CI: 10%-48%) while only one out of 8 patients with melanoma responded. The median response duration was 26 weeks (range 16-36 weeks). CONCLUSION: The planned high-dose intensity of ifosfamide and cisplatin could be reached only for the first 2-3 cycles. Haematologic toxicity, especially cumulative thrombocytopenia, necessitated treatment delays jeopardizing the dose intensity. The response rate in non-small-cell lung cancer and melanoma was not superior to what can be expected from more conventional regimens.

Adult↗
PubMed1995

Accelerated chemotherapy with high-dose epirubicin and cyclophosphamide plus r-met-HUG-CSF in locally advanced and metastatic breast cancer.

BACKGROUND: This study evaluated the toxicity of high-dose epirubicin and cyclophosphamide plus r-met-HUG-CSF (G-CSF) given every 2 weeks and compared the dose-intensity achieved with this schedule with that obtained in a previous study we conducted in which the same regimen was given every 3 weeks without G-SCF (EC 21). The secondary objective was to explore the activity of this regimen. PATIENTS AND METHODS: Between December 1991 and March 1994, 41 patients (pts), 19 with locally advanced breast cancer (LABC) and 22 with metastatic breast cancer (MBC), were given high-dose epirubicin (Hd-Epi) (120 mg/m2) and cyclophosphamide (CTX) (600 mg/m2) on day 1 every 14 days (EC 14) plus granulocyte colony-stimulating factor (G-CSF) (5 mcg/kg/d s.c. on days 2-12). A total of 8 cycles in LABC pts (4 pre- and post-surgery), and 6-8 cycles in MCB pts were administered. The results were compared with those obtained in the previous study. RESULTS: The incidence of WHO grade 3-4 neutropenia was significantly reduced in the EC 14 + G-CSF regimen (25.2% vs. 46.8% in 214 and 250 evaluable cycles, respectively, p<0.0001), as well as the incidence of neutropenic fever (7% vs. 3%, p=0.05). Grade 3-4 anemia (36.6% vs. 8% pts, p=0.001) and grade 3-4 thrombocytopenia (17.1% vs. 0 pts, p=0.002), were significantly more frequent in EC 14 + G-CSF. No significant differences in the other side effects were found. A total of 17 of 207 of the cycles (8.2%) were delayed in the EC 14 + G-CSF vs. 58/271 (21.4%) in the EC 21 (p<0.0001). The main reasons for these treatment delays were neutropenia (1% vs. 15%), anemia (3% vs. 0) and thrombocytopenia (1% vs. 0). As a result of treatment acceleration and differences in dose delays, the patients on EC 14 + G-CSF received a higher dose-intensity (Epi 58.51 mg/m2/wk vs. 36.8 mg/m2/wk; CTX 292.52 mg/m2/wk vs. 182.9 mg/m2/wk). A complete response at surgery was obtained in 9/19 (47.4%) LABC pts. An objective CR was obtained in 11/22 MBC pts (50%) and a partial response in 8/22 (36.4%), yielding an overall response rate of 86.4%. CONCLUSIONS: Hd-Epi + CTX is very active against both LABC and MBC. The administration of G-CSF allows dose intensification of both drugs (a 59.5% increase of the actual dose intensity) with acceptable clinical tolerance (a lower incidence of neutropenia but a higher incidence of anemia and thrombocytopenia). Only a specifically designed phase III trial will lead to definitive conclusions regarding the greater antitumor activity of accelerated CSF-including regimens as compared to standard chemotherapy for advanced breast cancer.

Adult↗
PubMed2005

Preoperative chemotherapy with epidoxorubicin, docetaxel and capecitabine plus pegfilgrastim in patients with primary breast cancer.

The objective of this pilot trial was to evaluate the safety and activity profile of epidoxorubicin, docetaxel and oral capecitabine plus pegfilgrastim (TEX+P) as preoperative first-line treatment for patients with breast cancer. Eleven consecutive patients were enrolled in this prospective clinical pilot trial. Preoperative treatment consisted of epidoxorubicin [75 mg/m2 body surface area (BSA)] and docetaxel (75 mg/m2 BSA) administered sequentially on day 1 in combination with oral capecitabine 2000 mg/m2 daily divided into two doses on days 1-14 of each 3-week treatment cycle. Pegfilgrastim 6 mg fixed dose was administered s.c. on day 2 of every treatment cycle. Patients received a total of 58 cycles (median 6 cycles, range 1-6) of this therapeutic regimen. Outpatient TEX+P was well tolerated. No WHO grade IV toxicity was observed. A pathological major response to this preoperative therapy regimen could be demonstrated in eight of nine evaluable patients leading to breast-conserving surgery in seven of nine evaluable patients. We conclude that outpatient TEX+P is safe in the neoadjuvant treatment of patients with primary breast cancer. Thus, this regimen can be considered for further clinical trials.

Adolescent↗
PubMed1997

Supportive therapies for cancer chemotherapy patients and the role of the oncology nurse.

Cancer chemotherapy often causes severe side effects, such as neutropenia, nausea and vomiting, and oral complications, which adversely affect patients' quality of life and may interfere with treatment success. A number of supportive therapies, such as colony stimulating-growth factors and antiemetics, have been developed to ameliorate these side effects, however, but often are underutilized. Oncology nurses, who serve as liaisons between oncologists and patients, can have a positive effect on patients' quality of life by educating them about potential side effects and the availability of supportive therapies, and by bringing patients' quality of life concerns and priorities to the attention of physicians. This article reviews the side effects of chemotherapy and the supportive therapies currently available to treat them and explores the role of oncology nurses as advocates for improved quality of life for chemotherapy patients.

Antiemetics↗
PubMed2003

Managing hematologic toxicities: novel therapies.

Myelosuppression associated with cancer chemotherapy may lead to neutropenia, anemia, or both, resulting in an increased risk for infection, fatigue, diminished quality of life, and reduced survival. In addition, neutropenia specifically has been shown to result in dose reductions, treatment delays, or both in subsequent chemotherapy cycles. Hematopoietic growth factors have been used effectively as supportive therapy to reduce chemotherapy-associated neutropenia and anemia. New preparations have the potential to improve treatment outcome dramatically. Results from recently reported studies indicate that patients at risk for neutropenia can be safely and effectively treated with pegfilgrastim once per chemotherapy cycle, and that those with anemia can be managed with weekly or biweekly darbepoetin alfa therapy. These new treatments have the potential to reduce the morbidity and mortality associated with opportunistic infections, decrease the requirement for potentially dangerous blood transfusions, and improve the quality of life for patients undergoing cancer chemotherapy. The longer dosing intervals offered by these new preparations may decrease healthcare expenses and enhance patient adherence.

Anemia↗
PubMedDate not supplied

Protocols for managing chemotherapy-induced neutropenia in clinical oncology practices.

Chemotherapy-induced neutropenia is managed in different ways in clinical practice. Chemotherapy dose reductions and delays are used more often than proactive, first-cycle use of colony-stimulating factors, but such dose modifications can result in suboptimal treatment outcomes. This article reviews how 3 oncology practices have used practice pattern studies to assess and improve their quality of care, particularly in the management of neutropenia. These practices analyzed their records for the occurrence of neutropenia and for delays or reductions in chemotherapy doses. Once baseline measurements of quality of care were established, the practices developed guidelines to optimize their management of neutropenia. The practice patterns were assessed again after the guidelines had been implemented, to determine the effect of these guidelines on clinical outcomes. All 3 practices had fewer delays and reductions of chemotherapy doses after the guidelines were used. These differences were both clinically and statistically significant. Clinical experience shows that nurses are well positioned to assess which patients may be at the greatest risk for neutropenia and its complications and therefore should be treated with colony-stimulating factors. Practice guidelines for the use of colony-stimulating factors are being developed, but broader acceptance of these guidelines is needed to support nurses' recommendations.

Antineoplastic Agents↗
PubMed2000

Recombinant human granulocyte colony-stimulating factor after kidney transplantation: a retrospective analysis to evaluate the benefit or risk of immunostimulation.

BACKGROUND: Leukopenia due to immunosuppressive drugs represents a well-known complication in graft recipients, which might put patients at an increased risk for infections. In this study, recombinant human granulocyte colony-stimulating factor (rhG-CSF), a hematopoietic growth factor that selectively stimulates neutrophil colony formation and neutrophil cell differentiation, was tested for safety and efficacy. METHODS: We evaluated 30 episodes of leukopenia (<2000/mm3) in 19 kidney graft recipients treated with rhG-CSF. This cohort was compared with an age- and sex-matched historical control group without therapy. Peripheral and differential blood cell counts were analyzed, and the duration of leukopenia was estimated. Furthermore, the occurrence of infections associated with leukopenia was investigated. RESULTS: All patients responded to rhG-CSF therapy. Peripheral leukocyte counts increased from 1756+/-582 to a peak of 8723+/-3038/mm3 (P<0.0001). On the average, the peak was reached after 2.7 days (range 1 to 8). Furthermore, the effect was fairly persistent, because in 22 of 30 episodes leukocyte counts were within the normal range after 7 days. The elevation of total leukocytes was mainly due to a specific increase in neutrophil granulocytes from 1143+/-514 to 6895+/-1950/mm3 on the peak day (P<0.0001). Patients in the G-CSF group were leukopenic for a mean of 1.29+/-0.59 days, whereas in the control group leukopenia persisted for at least 7 days. Consequently, the rate of infections was significantly higher (P<0.045) in nontreated patients. CONCLUSION: rhG-CSF was safe and effective in leukopenic kidney graft recipients. Leukopenic episodes in treated patients were significantly shorter, and infections occurred at a significantly lower rate. No evidence was found that rhG-CSF therapy might trigger rejection episodes, and no side effects were observed.

Antilymphocyte Serum↗
PubMed2002

Impact of granulocyte colony-stimulating factor use during induction for acute myelogenous leukemia in children: a report from the Children's Cancer Group.

PURPOSE: To determine whether granulocyte colony-stimulating factor (G-CSF) administered during acute myelogenous leukemia (AML) induction affects hematopoietic and nonhematopoietic toxicity, length and outcome of induction therapy, event-free survival, overall survival, and prognostic significance of the day 7 bone marrow. PATIENTS AND METHODS: In Children's Cancer Group study 2891, patients were given intensively timed induction with G-CSF (n = 254) after accrual for the regimen without G-CSF (n = 258) was met. RESULTS: Time to neutropenic recovery after induction courses 1 and 2 was significantly shorter for patients who received G-CSF. Times to platelet recovery were similar regardless of G-CSF use. Effects on incidence of grades 3 and 4 toxicities, infections, or fatal infections were not observed. Use of G-CSF reduced the median length of induction by 9 days and hospital stay by 6 days. Induction remission rates, overall survival, and event-free survival were similar with and without G-CSF. Day 7 bone marrow was prognostic of better long-term outcome. Patients with hypercellular day 7 marrow who received G-CSF had a higher remission rate and event-free survival than patients who did not receive G-CSF. CONCLUSIONS: The incidence of severe toxic event and infection, induction remission rate, overall survival, and event-free survival were comparable regardless of G-CSF use. Use of G-CSF decreased neutropenia duration, hospital stay, and length of induction. Patients with hypercellular day 7 bone marrow who received G-CSF had an induction remission rate and event-free survival superior to those of patients who did not receive G-CSF.

Acute Disease↗
PubMed1996

American Society of Clinical Oncology guidelines for the use of hematopoietic colony-stimulating factors.

The hematopoietic colony-stimulating factors have been introduced into clinical practice as additional supportive measures that can reduce the likelihood of neutropenic complications due to chemotherapy. Clinical benefit has been shown, but the high cost of colony-stimulating factors has led to concern about their appropriate use. The American Society of Clinical Oncology has established evidence-based, clinical practice guidelines for the use of colony-stimulating factors in patients who are not enrolled in clinical trials. An expert multidisciplinary panel reviewed the clinical data documenting the activity of colony-stimulating factors. For each common clinical situation, the panel formulated a guideline to encourage reasonable use of colony-stimulating factors to preserve effectiveness but discourage excess use when little marginal benefit is anticipated. Outcomes considered in evaluating colony stimulating factor benefit included duration of neutropenia, incidence of febrile neutropenia, incidence and duration of antibiotic use, frequency and duration of hospitalization, infectious mortality, chemotherapy dose intensity, chemotherapy efficacy, quality of life, colony-stimulating factor toxicity, and economic impact. To the extent that these data were available, the panel placed greatest value on survival benefit, reduction in rates of febrile neutropenia, decreased hospitalization, and reduced costs. Lesser value was placed on alterations in absolute neutrophil counts.

Adult↗
PubMed2005

Dose-dense primary systemic chemotherapy with gemcitabine plus epirubicin sequentially followed by docetaxel for early breast cancer: final results of a phase I/II trial.

We recruited 50 patients with T2-4 N0-2 M0 primary breast cancer into a phase I/II study to define the maximum tolerated dose (MTD), efficacy and tolerability of preoperative gemcitabine (1250 mg/m fixed dose) plus epirubicin (doses escalated from 90 mg/m) for 5 cycles followed by 4 cycles of docetaxel (scheduled fixed dose 100 mg/m) given on day 1 every 2 weeks (q2w) with pegfilgrastim support. The MTD for epirubicin was 100 mg/m, but the docetaxel dose had to be reduced to 80 mg/m. Dose-limiting toxicities included fatigue, stomatitis, diarrhea and dyspnea (all grade 3) during gemcitabine plus epirubicin, and fatigue (grade 3) and allergic reaction (grade 4) during docetaxel treatment, respectively. A pathologic complete response could be achieved in 13 patients (pT0+pTis, 26%), and in the breast and axilla in 12 patients [(pT0 or pTis)+pN0, 24%). Breast-conserving surgery (BCS) was possible in 35 patients (70%). Main grade 3/4 adverse events at MTD were fatigue (57/0%), leukopenia (27/8%), and liver (14/0%) and lung toxicity (14/0%). In conclusion, gemcitabine plus epirubicin 1250/100 mg/m q2w followed sequentially by docetaxel 80 mg/m q2w is highly effective as pre-operative chemotherapy with manageable toxicity. However, response and BCS rates could not be increased by administering gemcitabine plus epirubicin and docetaxel in a dose-dense fashion.

Adult↗
PubMed2006

Alternating intravenous and oral vinorelbine plus epirubicin with pegfilgrastim as neoadjuvant treatment of locally advanced breast cancer.

In order to downstage locally advanced breast cancer, neoadjuvant chemotherapy consisting of intravenous vinorelbine 25 mg/m plus epirubicin 75 mg/m given on day 1 and oral vinorelbine 60 mg/m on day 8 was administered every 3 weeks for four courses. On day 2, all patients received a single subcutaneous injection of pegfilgrastim (6 mg). From March 2004 to June 2005, 22 patients were enrolled. Patients characteristics were: median age, 53 years (range: 39-70 years); postmenopausal, 7/22; clinical TNM stage, T2 (n=14), T3 (n=8), N0 (n=17) and N1 (n=5). The median number of courses was four (range: two to six courses) with full dose intensity. National Cancer Institute grade 3 haematological toxicities observed were neutropenia in 9% of patients, anaemia in 13% of patients and thrombocytopenia in 9% of patients; no toxicity grade 4 occurred. Two patients (9%) registered grade 2 polyneuropathy; no cardiac failure was observed. Conservative surgery was performed in 14 patients (63%). All patients were evaluable for response: complete pathological response was documented in three patients (13.6%); three patients (13.6%) obtained more than 75% of tumour size reduction; 11 other patients (50%) had 50% of tumour size reduction; stable disease was observed in five patients (22.7%). The present findings indicate that vinorelbine in combination with epirubicin is an effective and safe treatment in locally advanced breast cancer: this regimen obtained more than 50% of tumour size reduction in 77% of patients; the use of pegfilgrastim allowed full dose intensity. Oral vinorelbine on day 8 offers greater convenience to the patient by reducing the need for intravenous injection and the time spent in hospital.

Administration, Oral↗
PubMed2006

Same day Pegfilgrastim and CHOP chemotherapy for non-Hodgkin lymphoma.

OBJECTIVES: To determine if "same day" Pegfilgrastim (Pf) with CHOP chemotherapy for non-Hodgkin lymphoma impacts on nadir white blood count (WBC) levels or on the nadir day. METHODS: Ten patients with non-Hodgkin lymphoma treated with CHOP-R; CHOP with liposomal Doxorubicin replacing H; or CVAD received 'same day' Pf in a minimum of one cycle of chemotherapy to a maximum of 6 cycles with 8 of 10 patients receiving same day Pf for some but not all cycles allowing for comparison of nadir WBC levels within patients. RESULTS: A total of 43 cycles of chemotherapy were reviewed. Same day Pf was administered with 21 of 43 cycles in all 10 patients with 8 of 10 receiving 22 cycles without Pf as well. White blood count nadir level and nadir day were compared in 9 patients in whom same day Pf was or was not administered in selected cycles. One patient experienced febrile neutropenia in a single cycle. Median nadir count and nadir day for cycles delivered with same day Pf was 1500 cells/ml (range, 200-11,000) at 14 days (range, 7-14 days). Median nadir count and nadir day cycles not delivered with same day Pf was 1600 cells/m and day 14 (range, 7-14), respectively. Four of 21 cycles (19%) delivered with same day Pf were associated with grade 4 leukopenia compared with 2 of 23 cycles (9%) delivered without same day Pf. With regard to the total 10 patient population 4 patients had a grade 4 leukopenia experience with same day Pf and 2 patients had a grade 4 leukopenia experience without same day Pf. Grade 4 leukopenia had a median nadir day of 7. CONCLUSIONS: Same day Pf may accentuate neutropenia in some patients with non-Hodgkin lymphoma receiving standard CHOP or CHOP-R chemotherapy but expanded studies are necessary to establish this point definitively. The accentuated neutropenia may be related to the specific chemotherapy regimen or drug, eg, cyclophosphamate since same day Pf was safe with regimens in which a non alkylating agent (taxane, gemcitabine, navelbine, cisplatin) was used with a weekly chemotherapy dosing schema and did not generate accentuated neutropenia.

Antibodies, Monoclonal↗
PubMed2006

A phase II study of docetaxel, doxorubicin, and infusional 5-fluorouracil in the treatment of patients with locally advanced breast cancer.

OBJECTIVE: The primary aim of this study was to estimate the rate of clinical and pathologic response to preoperative docetaxel, doxorubicin, and infusional 5-fluorouracil in patients with locally advanced breast cancer. Secondary objective included the determination of toxicity profile. PATIENTS AND METHODS: Thirty-nine patients (median age 49 years) with histologically confirmed locally advanced breast cancer (stage IIIA or IIIB) were studied. Patients received 4 courses of chemotherapy with docetaxel (75 mg/m2 iv over 1 hour), doxorubicin (50 mg/m2 iv bolus), and 5-fluorouracil (300 mg/m2/d as continuous iv infusion on days 1-5). Treatment cycles were repeated every 21 days. Prophylactic filgastrim 5 microg/kg s/c QD was administered to all patients. Definitive surgery was performed after the completion of 4 cycles of therapy. Pathologic complete response was defined as the absence of invasive cancer in both the breast and ipsilateral axillary lymph nodes. RESULTS: The clinical objective response rate (partial plus complete) was 87% (95% confidence interval [CI]: 76-98%). Three patients (8%) had complete pathologic response. Two patients progressed preoperatively. Thirteen patients (33%) developed neutropenic fever. Fifty-three percent of the patients were hospitalized for treatment related complications. No cardiotoxicity or treatment related deaths were observed. CONCLUSIONS: Triple cytotoxic therapy based on concurrent doxorubicin and docetaxel with infusional 5-flourouracil (5-FU) does not appear to significantly improve the pathologic response in patients with locally advanced breast cancer.

Adult↗
PubMed2005

Pegfilgrastim in pediatric cancer patients.

Chemotherapy-induced neutropenia is a major dose-limiting side effect of intensive chemotherapy in cancer patients. Recently, pegfilgrastim (a product with a long half-life, resulting in once-per-cycle dosage) was introduced to prevent neutropenia in adults. The authors report 32 episodes of pegfilgrastim use in seven pediatric cancer patients to diminish chemotherapy-induced neutropenia. Feasibility was assessed by adherence to treatment protocol and safety was assessed by adverse effects. There were only two treatment delays (6%) due to neutropenia. No short-term adverse effects were recorded. The use of pegfilgrastim is feasible in pediatric cancer patients, without short-term adverse effects or major treatment delay due to neutropenia.

Adolescent↗
PubMed2004

Perioperative granulocyte colony-stimulating factor does not prevent severe infections in patients undergoing esophagectomy for esophageal cancer: a randomized placebo-controlled clinical trial.

OBJECTIVE: Esophagectomy for esophageal cancer is associated with substantial postoperative morbidity as a result of infectious complications. In a prior phase II study, granulocyte colony-stimulating factor (G-CSF) was shown to improve leukocyte function and to reduce infection rates after esophagectomy. The aim of the current randomized, placebo-controlled, multicenter phase III trial was to investigate the clinical efficacy of perioperative G-CSF administration in reducing infection and mortality after esophagectomy for esophageal cancer. PATIENTS AND METHODS: One hundred fifty five patients with resectable esophageal cancer were randomly assigned to perioperative G-CSF at standard doses (77 patients) or placebo (76 patients), administered from 2 days before until day 7 after esophagectomy. The G-CSF and placebo groups were comparable as regards age, gender, risk, cancer stage, frequency of neoadjuvant radiochemotherapy, and type of esophagectomy (transthoracic or transhiatal esophageal resection). RESULTS: Of 155 randomized patients, 153 were eligible for the intention-to-treat analysis. The rate of infection occurring within the first 10 days after esophagectomy was 43.4% (confidence interval 32.8-55.9%) in the placebo and 44.2% (confidence interval 32.1-55.3%) in the G-CSF group (P = 0.927). 30-day mortality amounted to 5.2% in the G-CSF group versus 5.3% in the placebo group (P = 0.985). Similar results were found in the per-protocol analysis. CONCLUSION: Perioperative administration of G-CSF failed to reduce postoperative morbidity, infection rate, or mortality in patients with esophageal cancer who underwent esophagectomy.

Adult↗