A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy.

BACKGROUND: Docetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non-small cell lung cancer, and prostate cancer. OBJECTIVE: This is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel. METHODS: Patients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets. FINDINGS: A total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants' mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; P = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (P < 0.05) in patients receiving anthracyclines in their chemotherapy regimens. CONCLUSIONS: The findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (Curr Ther Res Clin Exp. 2022; 82:XXX-XXX) © 2022 Elsevier HS Journals, Inc.

Prophylaxis of neutropenic fever with ciprofloxacin in patients with acute myeloid leukemia treated with intensive chemotherapy.

AIMS: Neutropenic fever is one of the most serious complications after induction chemotherapy in acute myeloid leukemia (AML). Prophylaxis with antibiotics for prevention of neutropenic fever in AML is controversial and there are few studies on this issue from developing countries. METHODS: In this retrospective study, we analyzed the clinical data and outcome of patients with AML who did or did not receive prophylactic ciprofloxacin 500 mg BD for neutropenic fever. RESULTS: A total of 69 AML patients were treated by "3 + 7" protocol for their first induction chemotherapy. Prophylaxis was given to 25 of them. Incidence of neutropenic fever was the same in both groups (80% vs 82%). Duration of fever and the mortality rate were also similar in both groups. CONCLUSION: It seems that in developing countries, using prophylactic ciprofloxacin has no significant effect on the incidence of neutropenic fever and the outcome of the AML patients.

Modified Irinotecan Plus Cisplatin and Dexamethasone (ICD) Combination Chemotherapy as Salvage Chemotherapy for Patients with Relapsed/Refractory Diffuse Large Cell Lymphoma.

About 50 % of patients with diffuse large cell lymphoma are candidate for salvage chemotherapy followed by bone marrow transplantation in the selected patients. In the current study we evaluated modified ICD (Irinotecan, Cisplatin, and Dexamethasone with G-CSF support) as salvage chemotherapy in the patients previously treated with R-CHOP or CHOP. In a retrospective study we evaluated 16 patients treated with modified ICD: irinotecan 65 mg/m(2) (max 100 mg)/day plus cisplatin 30 mg/m(2) (max 50 mg)/day and dexamethasone 40 mg/day on days 1 and 8. Prednisolone 200 mg divided in 2 doses was given orally on days 2 and 9. G-CSF (PDgrastim) was administered at 300 µg/day subcutaneously on days 4-6 and 11-13. pre- and post-hydration was given according to our hospital protocol. Overall response rate was 75 % for all of the patients and 90 % for the patients treated as first line salvage. The median overall survival was 23 ± 12 months. There was no grade 3/4 of neutropenia and no cycles of chemotherapy were delayed due to leucopenia. Modified ICD might be an effective salvage regimen for refractory/relapsed lymphoma patients. Unlike original ICD, leucopenia does not seem to be a limiting factor. So we conclude that modified ICD shall be considered as a safe and effective regimen for salvage chemotherapy in refractory/relapsed patients.

Visual problem and low back pain as initial manifestation of multiple myeloma complicating pre-existing systemic sclerosis.

Some connective tissue diseases are associated with an increased risk of developing neoplastic disorders. Association of rheumatoid arthritis and systemic lupus erythematosus with lymphoma, and of dermatomyositis with different malignancies including ovarian and lung cancer has been reported in the literature. Here, we describe a 58 years old man with systemic sclerosis (SSc) for 15 years who developed severe lumbar pain when he was admitted for intravenous infusion of prostaglandin E1 for his fingertip ulcers. He was found to have abnormal skeletal imaging. Laboratory tests including bone marrow aspiration and biopsy determined multiple myeloma causing extensive bony infiltration. The patient expired after two cycles of VAD and Bortezomide chemotherapy.