Introduction: Patients with brain metastases have commonly been denied bevacizumab treatment because of the suspected risk of central nervous system (CNS) hemorrhage. Although safety information on bevacizumab treatment of non-small-cell lung cancer (NSCLC) with CNS metastases has been accumulated, its use is still controversial. We conducted the present retrospective study to investigate bevacizumab safety in patients with NSCLC and brain metastases. Methods: Clinical data of NSCLC patients treated with chemotherapy regimens containing bevacizumab in a single institution from Feb. 2010 to Nov. 2011 were assembled retrospectively from medical records. Hematologic toxicity, non-hematologic toxicity, progression-free survival (PFS), and overall survival (OS) were analyzed. Results: Fifty two patients were included in this analysis of whom 10 had brain metastases. Incidence of grade ≥3 major bleeding events such as CNS hemorrhage and pulmonary hemorrhage were not observed in either group. Neither were there any differences in toxicity profiles between groups. The median OS and PFS of all patients were 13.1 months (95% confidence interval (CI), 10.7 - not reached) and 9.1 months (95% CI, 4.1 - 11.1 months), respectively. No significant differences in median OS or PFS were observed between the two groups. Conclusion: These data suggest that bevacizumab treatment may be safe for NSCLC with brain metastases and deserves further study.
Background:Previously, we reported that the maximum tolerated dose (MTD) of biweekly administration of irinotecan (CPT-11) plus cisplatin (CDDP) was 70 mg/m2 plus 30 mg/m2, respectively. The same biweekly regimen was combined with intestinal alkalization to address delayed diarrhea in this phase I study. Methods: CPT-11 plus CDDP were administered biweekly with an antidiarrheal program consisting of sodium bicarbonate and magnesium oxide to patients with various malignancies. CDDP dosing was fixed at 30 mg/m2 and dose escalation of CPT-11 from 60 mg/m2 to 100 mg/m2 by a step of 10 mg/m2 was used. Results: A total of 22 patients (Level I (60 mg/m2): 3 patients, Level II (70 mg/m2): 3 patients, Level III (80 mg/m2): 7 patients, Level IV (90 mg/m2): 6 patients, and Level V (100 mg/m2): 3 patients) entered into this study. Of the 22 patients, diarrhea of grade 2 and 3 was observed in 3 patients and 1 patient (5%), respectively. At Level IV, 2 patients experienced grade 3 neutropenia, and one of the 2 patients coincidentally had grade 3 thrombocytopenia and grade 3 diarrhea. At Level V, there were no patients with dose limiting toxicities, but 2 of the 3 patients could not be dosed more than three times. Of the 22 patients, 19 patients were assessed for response. One and 12 patient had partial response and stable disease, respectively, resulting in a disease control rate of 68%. Conclusion: Intestinal alkalization could prevent CPT-11-induced diarrhea and increase MTD of biweekly 100 mg/m2 of CPT-11 with CDDP 30 mg/m2 administration.
Carcinomatous meningitis (CM) is a severe complication of lung cancer. Here, we report on two EGFR-mutated patients who attained relatively long survivals by erlotinib treatment after diagnosis of CM. The first case is a 59-year-old woman who was diagnosed as adenocarcinoma harboring an EGFR mutation (L858R); her disease was at stage IV with multiple brain metastases. The time from the initial diagnosis of lung cancer to CM was 364 days. Erlotinib was administered for 5 months, and the survival time from the diagnosis of CM was 278 days. The second case is a 60-year-old man who underwent right lower lobe lobectomy and was diagnosed as adenocarcinoma with an EGFR mutation (E746-750 deletion) and at the pathological stage IIA (pT1N2M0). Later, the disease was recurring as brain metastasis, and progressed to CM 637 days after diagnosis of lung cancer. Erlotinib was administered for 5.5 months, and the survival time from the diagnosis of CM was 281 days. These cases indicate that erlotinib is a reasonable option for the treatment of CM in EGFR-mutated patients.
Purpose: Five-hydroxytryptamine-3 (5-HT3) receptor antagonists (RAs) are widely used to control chemotherapy-induced nausea and vomiting in cancer chemotherapy. Several 5-HT3 RAs could be available, there are some important points to select agents, like as efficacy, adverse events and their costs. In this study, we compared an originator drug, azasetron with a generic version, granisetronNK, to evaluate their anti-emetic efficacy and quality of life in crossover randomized setting. Patients and Methods: Patients treated with a highly emetic FEC100 regimen are registered in this study. Patients randomly assigned to 2 groups, which treated with granisetron NK in first course followed second course treated with azasetron, or vice versa. Efficacy, adverse events and quality of life (QOL) were evaluated with patient self-reporting questionnaires. Results: Twenty seven patients were recruited to this study. Fourteen patients were assigned to receive azasetron in first course followed by granisetronNK in second course, and 13 patients were assigned to receive granisetronNK in first course followed by azasetron in second course. There was no significant difference in grade and frequency of nausea, vomiting, eating status and defecation between two treatment groups. In addition, analysis of QOL showed no significant difference in two groups. Conclusion: A generic 5-HT3 RA granisetronNK which reduce 31% cost showed no significant differences in terms of efficacy, adverse events and QOL in comparison with originator drug azasetron. Effective and high cost-performance supportive therapy should be chosen.
Background: This study used focus groups to examine the content validity and feasibility of the Care Notebook among Hawaii residents. Methods: Focus groups were held for Hawaii cancer survivors, caregivers, and cancer clinical trials professionals. The focus groups followed a standardized set of questions, and all participants were provided with the Care Notebook, a 24-item instrument, scored on an 11-point Likert scale, with an open-ended question (“How might we help you improve your health and life?”). Results: A total of 20 patients, 4 caregivers, and 9 health professionals took part in the focus groups. Focus groups identified two primary themes: quality of life (QoL) concerns are important to cancer survivors; and most patients are comfortable with the idea of using a questionnaire to measure QoL. In terms of the Care Notebook specifically, the groups observed that items on the Care Notebook are relevant to Hawaii cancer survivors; and the “other comments” final question of the Care Notebook is very important and could be expanded to make the questionnaire responsive to the concerns of individuals. Participants also pointed out that there were a few areas where they found the wording was confusing. Conclusion: Most cancer survivors feel comfortable with using a questionnaire to measure QoL concerns, which are important to them; and caregivers and heath professionals agree with these observations. This study gives credence to use of English version of the Care Notebook, as well as provides suggestions for ways it could be improved.