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FOUR YEARS EXPERIENCE WITH COMBINED WEEKLY NON-PEGYLATED LIPOSOMAL DOXORUBICIN AND TAXANE IN BREAST CANCER SECOND-LINE TREATMENT
No full textBiosimilar filgrastim in routine clinical practice: a single centre experience.
No full textIntroduction: The use of recombinant human granulocyte colony-stimulating factors (rh-G-CSF) has significantly increased the ability to maintain effective schedules and doses of chemotherapy regimens with severe medullary toxicity. However, despite numerous guidelines, the use of rh-G-CSFs in clinical practice is often suboptimal, occurring on a non-systematic case-by-case basis. The availability of biosimilar filgrastim at significantly reduced costs may allow more patients to benefit from growth factor support with comparable results to the originator filgrastim in terms of febrile neutropenia (FN) risk reduction. We performed a retrospective data analysis of 42 patients who underwent chemotherapy for advanced solid tumours and received primary prophylaxis with biosimilar filgrastim (Zarzio®).
Methods: All hospital day patients with an expected risk of FN >20% based on their scheduled chemotherapy regimen received 3 days (days 2−4) primary prophylaxis with subcutaneous bolus injections of Zarzio® 300 μg. Patients with FN < 20% and poor bone marrow reserve or other severe co-morbidities and at high risk for infection also received primary prophylaxis. Blood tests were performed at the nadir and the day before the next cycle of treatment. Patients were usually asked to repeat each test in the same laboratory. The primary end-point was the efficacy and tolerability of primary prophylaxis with Zarzio® in terms of severe neutropenia and overall FN incidence and duration in unselected cancer patients in routine clinical practice. Treatment related toxicity (predominantly muscle-skeletal events) was evaluated through the NCI CTC 3.0.
Results: We analysed data from 42 patients (male, n=14; female n=28) with advanced solid tumours (breast, n=15; endometrial/ovarian, n=7; non-small-cell lung, n=6; gastric, n=5; others, n=9) who received primary prophylaxis with Zarzio® for FN. Median age was 58 years (range: 26−82), with one-third of patients (n=14) aged ≥65 years. Median body weight was 68 kg (range 44−101). Eighteen patients received primary prophylaxis because of an FN risk >20% and 24 because of associated co-morbidities. A total of 185 chemotherapy cycles was administered (median 4.4 cycles/patient). Zarzio® was administered 538 times (median 12 administrations/patient). Severe neutropenia (ANC ≤ 1100 x 109/L) was recorded in 24/401 blood tests. None of the patients developed FN. Musculoskeletal event (arthralgia, myalgia, bone pain) after Zarzio® administration were as expected ; two patients reported cutaneous rash and one patient had hypotension. There were no significant differences between the elderly population (aged ≥65 years) and patients aged <65 years in terms of toxicity or severe neutropenic events (11 versus 13 events, OR: 0.57, 95% CI 0.24−1.31, p= 0.18).
Conclusion: Our retrospective analysis in unselected patients confirmed the efficacy and safety profile of Zarzio® in routine clinical practice. No patients developed FN or had delayed treatment because of severe neutropenia. Elderly patients (33.3% of the study population) did not differ significantly from other patients in terms of treatment tolerability and efficacy
ONE YEAR OF BIOSIMILAR FILGRASTIM IN ROUTINE CLINICAL PRACTICE
No full textObjectives: The use of biosimilar filgrastim has been debated for the limited experience at the time of the approval. We performed a retrospective data analysis of 52 patients who underwent and completed a chemotherapy line for advanced solid tumour and received primary (n=46) or secondary (n=6) prophylaxis with biosimilar filgrastim (Zarzio®). Methods: All hospital day patients with an expected risk of FN >20% (n=21) or FN risk < 20% at high risk for infection (n=25), received 3 days (days 2−4) primary prophylaxis with subcutaneous bolus injections of Zarzio® 300 μg/die. Uneligible patients who developed severe neutropenia after the first cycle, received secondary prophylaxis. Blood tests were performed at the nadir and the day before chemotherapy. The primary end-point was to evaluate the efficacy and tolerability of Zarzio® in terms of severe neutropenia or overall FN incidence and duration. Results: Our retrospective data analysis involved 52 patients (median age 59.2 years) with fifteen aged ≥65 years and median body weight of 70 kg who received a total of 243 chemotherapy cycles (median 4.6 cycles/patient) and 651 Zarzio® administrations (median 12.5 administrations/patient). Severe neutropenia was recorded in 29/452 blood tests. None of the patients developed FN. Two patients received prophylactic antibiotics for severe neutropenia. None of the patients delayed the treatment for bone marrow toxicity. Conclusion: Our data confirmed the efficacy and safety of Zarzio® in routine clinical practice. The use of a three days schedule is actually under debate; longer schedule (5 up to 10 days) could improve the outcome
Breast cancer in young women. Case report
No full textBACKGROUND: Breast cancer in patients under 40 years is uncommon. Surveillance, Epidemiology and End Results (SEER) program reveals that 75% of breast tumors occur in women age 50 years, only 6.5% in women age 40 years, and a mere 0.6% in women age 30 years. Breast-conserving surgery with subsequent chemo-radiotherapy has become the treatment of choice in women with breast neoplasm. CASE REPORT: Two young patients, 30 and 28 years respectively, with breast cancer. One patient with an atypical medullary breast carcinoma diagnosis, pT2 pN1 bipMx, Grade 3 Stage IIB, negative for receptors, Ki 67: 47%, cERB-2 negative; the other with an intraductal breast carcinoma, pT1c pN0 pMx, Grade 2 Stage I, negative for receptors, Ki 67: 85%, cERB-2 negative, p53 negative, Bcl-2 negative. The first patient underwent right radical mastectomy sec. Madden and axillary lymphoadenectomy in October 2001, started six cycles of adjuvant chemotherapy and radiotherapy on the right side of the chest and on axillary and supraclavicular lymph nodes area. After 2 years an ecotomography revealed small hypoechogenic nodules in the left breast. In December the patient underwent left radical mastectomy with positioning of an expander device. The histological exam revealed a not much differentiated intraductal carcinoma, pT1a N0 Mx, Stage I. After the surgical therapy, she follows another adjuvant chemotherapy. The second patient underwent left quadrantectomy with axillary limphoadenectomy in November 2004. Like the first-will follow several cycles of adjuvant chemotherapy and radiotherapy. DISCUSSION: Breast cancer in women under 40 years of age differ from breast cancer in older women in numerous clinical, pathological and biological features. The studies demonstrate that breast cancer arising in women under 40 years have a more aggressive profile than those of older patients. In both our patients family history of breast cancer was reported. That suggests a possible genetic susceptibility of these patients through BRCA1 and BRCA2 germ-line mutations. Breast conservative surgery with chemio-radiotherapy is the most commonly used treatment breast cancer, expecially in consideration of the aggressiveness of the lesions
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