Impact of Primary Pegfilgrastim Prophylaxis on Relative Dose Intensity in Neoadjuvant/Adjuvant FEC-100 Chemotherapy.

BACKGROUND/AIM: This study aimed was to clarify the impact of pegfilgrastim (PEG) 3.6 mg primary prophylaxis of febrile neutropenia (FN) on the average relative dose intensity (ARDI) of neoadjuvant/adjuvant FEC-100 for breast cancer. MATERIALS AND METHODS: This retrospective, single-centre cohort study including 296 patients who received FEC-100 compared PEG and non-PEG groups. The PEG group received PEG 3.6 mg as a single subcutaneous injection in each study cycle. The primary endpoint was the ARDI of FEC-100. The secondary endpoints were patient percentage of ARDI≥85%, factors associated with ARDI≥85%, and reasons for reduced ARDI. RESULTS: The PEG group showed significantly higher mean ARDI (95.6% versus 90.7%, p<0.001) and patient percentage of ARDI≥85% (93.0% versus 79.9%, p=0.001). PEG was significantly associated with ARDI≥85% (p=0.009). Neutropenia and FN, the main reasons for reduced ARDI, were significantly lower in the PEG group (p<0.05). CONCLUSION: Primary PEG 3.6 mg prophylaxis increased the ARDI of FEC-100.

[Efficacy of preventive treatment for delayed emesis induced by FOLFOX4 chemotherapy].

The control of delayed emesis is very important in order to continue ambulatory chemotherapy. We performed retrospective study that examined the efficacy of preventive treatment (granisetron+dexamethasone+domperidone) for delayed emesis induced by FOLFOX4 chemotherapy for advanced and recurrent colorectal cancer. The subjects were 92 patients who underwent FOLFOX4 chemotherapy at the Cancer Institute Hospital of JFCR (group with preventive treatment: 50, group without preventive treatment: 42), and the observation period was set as the 1st-9th cycle. The complete nausea inhibition rate was 50.0% in the group with and 21.5% in the group without preventive treatment, showing a significantly higher inhibition rate in the former (p=0.0047). The complete vomiting inhibition rates were 86.0% and 66.7%, respectively, again showing a significantly higher inhibition rate in the former (p=0.015). On multivariate analysis (multiple logistic analysis), the development of nausea/vomiting and preventive treatment for delayed emesis were significantly associated, showing that the treatment was an independent preventive factor. All adverse reactions induced by preventive treatment were mild, suggesting no safety-related problem. These findings suggested the usefulness of preventive treatment with granisetron, dexamethasone, and domperidone for FOLFOX4 chemotherapy-induced delayed emesis.

[Relative dose intensity of FOLFOX4 regimen].

PURPOSE: Oxaliplatin (L-OHP) is one of the key drugs against advanced, recurrent colorectal cancer, and FOLFOX4 regimen combination of l-leucovorin (l-LV)and 5-fluorouracil (5-FU)with oxaliplatin is a standard therapy in colorectal cancer. We performed a retrospective study that researched adverse events and relative dose intensity(RDI)to evaluate safety and feasibility of FOLFOX4 regimen. PATIENTS AND METHODS: We administered 188 patients a FOLFOX4 regimen. To evaluate RDI, this study research dose modification and delay treatment procedure was done for 1 to 13 cycles. RESULTS: RDI of oxaliplatin is 89.1% (1-4 cycles), 81.4% (4-7 cycles), 78.2% (7-10 cycles), 69.0% (10-13 cycles). The factors of RDI decrease were hematologic toxicity(leucopenia, neutropenia, thrombocytopenia), peripheral neuropathy and allergic reaction. Moreover, peripheral neuropathy and allergic reaction often require therapy to be discontinued (peripheral neuropathy: 15.2%, allergic reaction: 20.3%). CONCLUSION: Feasibility of FOLFOX4 regimen is related to incidents of hematologic toxicity, peripheral neuropathy and allergic reaction. We should pay sufficient attention to these adverse events of FOLFOX4.

Modified irinotecan plus bolus 5-fluorouracil/L-leucovorin for metastatic colorectal cancer at a single institution in Japan.

BACKGROUND: The modified irinotecan plus bolus 5-fluorouracil/L-leucovorin (IFL) regimen (irinotecan plus bolus 5-fluorouracil/L-leucovorin) used to be one of the standard treatments for metastatic colorectal cancer until approval of oxaliplatin in Japan. We evaluated the efficacy of modified IFL therapy for Japanese patients. METHODS: Forty-seven patients with metastatic colorectal cancer received irinotecan (100 mg/m(2)) and bolus 5-fluorouracil (500 mg/m(2)) plus L-leucovorin (10 mg/m(2)) on days 1 and 8 every 3 weeks until progression or unmanageable toxicity occurred. The data on toxicity and tumor response were analyzed retrospectively. RESULTS: All patients discontinued modified IFL therapy due to cancer progression, except for one patient who developed severe liver dysfunction. The overall response rate was 25%. The median progression-free survival time (PFS) was 8.6 [corrected] months. The median overall survival time (OS) was 27.8 [corrected] months for all patients, 30.9 [corrected] months for patients receiving subsequent oxaliplatin therapy, and 14.5 [corrected] months for patients without oxaliplatin (P = 0.0031). According to multivariate analysis results, good performance status, a normal white cell count, and absence of local recurrence were associated with a better PFS. Tumor response was a good prognostic factor for both PFS and OS. Gastrointestinal symptoms were the most common toxicities, including grade 3 diarrhea (8%) and grade 3 anorexia (10%). Grade 4 neutropenia occurred in 6% of patients. No other drug-related severe adverse events or deaths were observed. CONCLUSIONS: Modified IFL therapy is an effective and well-tolerated regimen for Japanese patients with metastatic colorectal cancer. Modified IFL therapy combined with biological agents might remain an option for some patients who refuse a central venous catheter.