MDCT classification of tumor distribution before neoadjuvant chemotherapy and of shrinkage patterns after neoadjuvant chemotherapy is important in the preoperative evaluation of patients undergoing breast-conserving surgery.
Background. The effect of low-dose 5-fluorouracil (FU) and cisplatin therapy (FP regimen) against metastatic breast cancer was investigated. Methods. A pilot study of the FP regimen was performed in 11 patients with metastatic breast carcinoma who had previously received chemotherapy, including adriamycin, and/or hormonal therapy. Their median age was 56 years (range, 48-72 years). Visceral metastases were present in all patients. FU, at a dose of 170 mg/m(2) per day, was administered for 28 days by continuous intravenous infusion. Cisplatin (7 mg/m(2) per day) was given intravenously on days 1-5, 8-12, 15-19, and 22-26. After a 2-week interval, this treatment was repeated. Results. Of the 11 patients assessable for tumor response to the FP regimen, 4 patients (36%; 95% confidence intervals [CI], 8%-64%) achieved an objective response, with 1 showing a complete response and 3 showing a partial response. Median time to progression was 6.5 months (range, 4-25 months). The median survival time from the initiation of the FP regimen was 11 months (range, 3-25 months). Gastrointestinal and hematologic toxicity was mild. Conclusion. The FP regimen is promising for and has acceptable tolerance in patients with metastatic breast carcinoma refractory to previous anthracycline-containing chemotherapy.
We present a case of adriamycin-and docetaxel-resistant inflammatory breast cancer (IBC) in which partial response was achieved with combination therapy using trastuzumab and paclitaxel. A 48-year old woman noticed a lump in her right breast. She was diagnosed with IBC and the disease was staged as T4d N1 M0, stage III B. The patient was started on neoadjuvant chemotherapy with adriamycin (50 mg/m2) and docetaxel (60 mg/m2) administered every three weeks. Six courses were performed and the response was evaluated as no change. After one month, contralateral breast swelling indicated bilateral IBC. Bilatera1 mastectomy using the Halsted method was performed. The immunohistochemical results of the Hercep Test was strongly positive (3+). After the mastectomy, right pleural effusion appeared, and cytological examination revealed the cells to be classV(adenocarcinoma). To treat the clinically advanced breast cancer, combination therapy with trastuzumab (initially 4 mg/kg followed by two or more cycles of 2 mg/kg) and paclitaxel (80 mg/m2) were given intravenously every week for eight cycles and then every two weeks thereafter. A total of 32 courses of therapy were performed, the pleural effusion completely disappeared and partial response was maintained for a duration of 482 days. The adverse reactions were mild, and it was possible for her to be treated as an outpatient with high quality of life. This report suggests that weekly combination therapy of trastuzumab and paclitaxel was useful for treatment of adriamycin-and docetaxel-resistant metastatic breast cancer.
We have been successfully using a patient's record notebook in home-based outpatient cancer chemotherapy since 2003. Many of the patients expressed their satisfaction carrying a patient record notebook through our questionnaires designed to illicit details of their side effects during the chemotherapy. There are so many tasks the patient has to do by his own once he leaves the hospital and to become an outpatient. One of the important tasks the patient has to do is how to take care of the side effect by himself. In fact, some of the patients had a difficulty in evaluating their own side effect symptoms. In evaluating the side effect of patients by a pharmacist, he should not rely on the patient record notebook alone, but careful attention has to be paid to a patient's general condition by our medical team members consisting of inpatient pharmacists, surgeons, chemotherapists, palliative care physicians, nurses, social workers and others. In order to proceed with the safety of chemotherapy, it is critical to have a consensus based on medical policies concerning the reduction of side effects and to support the fight against cancer with the medical team members. The results also suggest that the patient record notebook is more useful for pharmacists in controlling of side effects and to adopt a prudent policy for chemotherapy.
Funding Acknowledgements Otsuka Pharmaceutical Co. Ltd. On Behalf OPC-61815 phase II investigators Background/Introduction: Tolvaptan, a vasopression V2-receptor antagonist, is effective for congestion in patients with congestive heart failure (CHF), and hyponatremia in patients with CHF and SIADH. But, this drug is not readily soluble in water and not suited for development as an injection. OPC-61815, a prodrug of tolvaptan having improved water solubility, is suitable for intravenous administration. Purpose The phase-II clinical study (ClinicalTrials.gov Identifier: NCT03254108) was conducted to investigate the dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet in CHF patients. Methods This study was a multicenter, a double-blind, randomized, active-controlled, parallel-group comparison clinical pharmacology trial. Sixty patients aged between 20 and 85 years with CHF with volume overload despite the use of conventional diuretics were randomly assigned to four treatment cohorts to receive OPC-61815 at doses of 2, 4, 8, 16 mg (i.v.) or tolvaptan at 15 mg (p.o.). Both drugs were administered once a day for 5 days. The primary endpoint was to assess the dose of OPC-61815 equivalent to tolvaptan at 15 mg using Cmax and AUC24h values after the first administration. Pharmacodynamics (urine volume, urine osmolality, serum electrolyte concentration, biomarkers), efficacy (body weight change, congestive symptoms) and safety were also evaluated. Results The mean Cmax and AUC of the metabolite tolvaptan increased dose-dependently following single intravenous administration of OPC-61815 at 2, 4, 8, and 16 mg. Tolvaptan exposure (Cmax and AUC24h) on Day 1 following single intravenous administration of OPC-61815 at 16 mg was the closest and similar to that following single administration of tolvaptan 15-mg tablet. OPC-61815 increased urine volume from baseline, leading to decrease in body weight and improvement of lower limb edema. The incidence of treatment-emergent adverse events was 54.2% (26/48 subjects) in the OPC-61815 2 to 16-mg, and 83.3% (10/12 subjects) in the tolvaptan 15-mg groups. No clinically relevant changes from baseline were found in laboratory parameters, vital signs, or ECG findings. Conclusions Tolvaptan exposure on Day 1 following single intravenous administration of OPC-61815 at 16 mg was the most similar to that following single administration of tolvaptan 15-mg tablet. There was no marked difference in tolerability between OPC-61815 at 16 mg and tolvaptan 15-mg tablet, and no clinically significant problems were observed.
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