A phase II trial of docetaxel and CPT-11 in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and gastric cardia

Purpose. The incidence of adenocarcinoma of the lower third of the esophagus, esophagogastric junction, and gastric cardia has been rising in the face of limited treatment options for patients with metastatic disease. With the emergence of data to suggest that single agent docetaxel and irinotecan carry antineoplastic effects in this setting, we determined the response rate of these agents when given in combination. Patients and Methods. Forty-six patients with metastatic adenocarcinoma of the lower third of the esophagus, esophagogastric junction, and gastric cardia were evaluated. Patients received docetaxel 50 mg/m²/d and irinotecan 130 mg/m²/d intravenously at 21-d intervals with a tumor assessment after 2 cycles. Because of unacceptable toxicity among the first 13 patients, dosing was reduced to docetaxel 40 mg/m²/d and irinotecan 100 mg/m²/d intravenously at 21-d intervals. Results. The response rate for the entire cohort was 26% (95% confidence interval: 14%, 41%) with 12 confirmed partial responses. Five of these 12 responses were observed in patients treated at the higher chemotherapy dose. However, because 8 of 13 patients suffered grade 4 neutropenia and fevers, a dose reduction was incorporated into the protocol, and the remainder of the cohort was treated at the lower dose. All except 4 of the 15 observed grade 4 toxicities occurred at the higher dose, and these toxicities included nausea and vomiting, dyspnea, hypotension, dysrhythmias, and diarrhea in addition to neutropenia and fevers. There were no grade 5 toxicities. The median survival for the entire cohort was 7.3 mo. Conclusion. The combination of docetaxel and irinotecan provides modest antineoplastic activity among patients with adenocarcinoma of the esophagus, esophagogastric junction, and gastric cardia. Doses of docetaxel 40 mg/m²/d and irinotecan 100 mg/m²/d at 21-d intervals provide an acceptable safety profile, but higher doses appear to result in unacceptable toxicity.     

Internal mammary sentinel nodes in primary breast cancer

For over a century, there has been considerable interest in the management of regional lymph node metastasis in patients with primary breast cancer. Since the advent of sentinel lymph node biopsies, there has been renewed interest in the management of patients with metastasis to the internal mammary nodes. The appropriate management of these patients has not yet been established. Some investigators propose that biopsy of the internal mammary sentinel node may provide additional prognostic information which might be used to guide the administration of systemic adjuvant therapy. Additionally, it has been suggested that patients with metastasis to the internal mammary sentinel node may benefit from radiotherapy to the internal mammary nodal chain. Clinical trials are needed to resolve these issues. Internal mammary sentinel node biopsy in patients with primary breast cancer should be considered investigational, and conducted only in the context of clinical trials.     

Weekly carboplatin and paclitaxel in elderly non-small-cell lung cancer patients (>or=65 years of age): a phase II North Central Cancer Treatment Group study

The purpose of this study was to determine the tumor response rate and toxicity profile of low-dose weekly carboplatin and paclitaxel in advanced non-small-cell lung cancer (SCLC) patients 65 or more years of age. Forty-nine patients 65 years of age or more with advanced non-SCLC with a median age of 73 years (range: 65-85) and an Eastern Cooperative Oncology Group performance status of 0, 1, or 2 in 31%, 47%, and 22% of patients, respectively, were treated and evaluated. Patients received carboplatin (AUC = 2) and paclitaxel 50 mg/m2 on days 1, 8, and 15 of a 4-week cycle. The overall confirmed tumor response rate was 14% (95% CI: 4.7%, 32.5%) with no complete responses. The 1-year survival rate was 31% (95% CI: 20%, 48%). There was one treatment-related death, and there were two grade IV allergic reactions to chemotherapy. No other grade IV or V treatment-related toxicities were observed. There were only three episodes of grade III myelosuppression. Low-dose weekly carboplatin and paclitaxel, as prescribed in this trial, provides modest activity in the treatment of advanced non-SCLC patients 65 or more years of age. However, the relatively mild toxicity profile observed in this trial suggests that this regimen might remain an option for patients at increased risk for myelosuppression or with a poor performance status.     

Ectopic ovarian pregnancy

A case of ectopic ovarian pregnancy is presented occurring in a 24 years old woman after natural conception. The clinical diagnosis was ruptured tubal pregnancy. Gross findings were suggestive of ruptured corpus luteum cyst on exploration. The histopathological examination of specimen brought forward the diagnosis of ovarian pregnancy.     

Folate status among patients with non-small cell lung cancer: a case-control study

BACKGROUND AND OBJECTIVES: This case control study explored the purported inverse relationship between folate status and lung cancer development. METHODS: Folate status of 46 postoperative non-small cell lung cancer (NSCLC) patients was compared to that of 44 non-cancer patients. Cancer patients had completed treatment > 3 months prior and had no evidence of cancer. Ineligibility criteria for all patients included (1) > 2 alcoholic drinks/day (2) ongoing tobacco use, or (3) folate supplementation > 400 microg/day. RESULTS: No differences were found between groups in serum and RBC folate after adjustment for age and use of folate-interfering medications: geometric means (GM) x /geometric standard error (GSE): 7.9 ng/ml x /1.1 vs. 7.8 ng/ml x /1.1, respectively (P = 0.91) for serum folate; 264 ng/ml x /1.1 vs. 263 ng/ml x /1.1, respectively (P = 0.97) for RBC folate. Age- and creatinine-adjusted homocysteine was no different between groups: GM x /GSE: 9.4 micromol/L x /1.0 vs. 8.6 micromol/L x /1.0, respectively (P = 0.17). No difference were seen in folate intake. Frequencies of the homozygous genotype for the MTHFR polymorphism, an enzyme important in folate metabolism and associated with a reduced risk of other cancers, were no different. CONCLUSIONS: This case control study does not support the hypothesis that low folate is an independent risk factor for NSCLC.     

If you hold it off-hours,will they come? Results from a feasibility project intended to stimulate interest in the physician-investigator career path among medical oncology trainees

Background. An “endangered species,” the physician-scientist faces challenges in oncology. The authors thus implemented a series of voluntary off-hours sessions on academic development for their trainees. Methods. Numerous workday interruptions among trainees led the authors to conclude that off-hours sessions would be preferable. Thus, this feasibility project was conducted. All 34 trainees were invited to a session and were surveyed thereafter. An attendance rate of ≥34% was to be a “success.” Results. Seventy percent of trainees attended, and over 90% said they would do so again. Write-in comments were mostly favorable. Conclusions. Off-hours sessions to discuss academic career development are feasible among medical oncology trainees.     

Daily activities: exploring their spectrum and prognostic impact in older, chemotherapy-treated lung cancer patients

BACKGROUND: Performance scores predict benefits and toxicities from chemotherapy. Among older cancer patients, however, many investigators have empirically called for a detailed assessment of activities of daily living, claiming that the utility of performance scores is limited in this older population. This study's goals were therefore twofold: (1). to explore the predictive capability of an activities questionnaire and of performance score with respect to chemotherapy's toxicity and efficacy; (2). to describe the daily activities of older patients as they undergo chemotherapy for incurable metastatic lung cancer. METHODS: As part of a multi-institutional therapeutic trial, this study included 48 patients >or=65 years of age with metastatic non-small-cell lung cancer. All were assigned an Eastern Cooperative Oncology Group (ECOG) performance score and completed an activity questionnaire (Voorrips) prior to the initiation of carboplatin and paclitaxel. Patients were monitored for toxicity (CTC, version 2) and cancer status. RESULTS: Within this cohort, ECOG performance scores were poor at predicting grade 3 or worse toxic events ( P=0.71, Mantel-Haenszel chi-squared). In contrast, the activity questionnaire categories did predict grade 3 or worse toxicity ( P=0.03) with a positive association observed between greater levels of activity and lower toxicity rates. Neither instrument predicted 90-day disease progression, although there was a trend that suggested a positive association between favorable scores and lower progression rates ( P=0.051). Patients described a broad range of daily activities. CONCLUSION: Activity questionnaires capture a broad range of data that may prove useful in predicting toxicity among older cancer patients.     

Exploring therapeutic decisions in elderly patients with non-small cell lung cancer: results and conclusions from North Central Cancer Treatment Group Study N0222

How do oncologists choose therapy for the elderly? Oncologists assigned patients aged 65 years or older with incurable non-small cell lung cancer to: (a) carboplatin (AUC = 2) + paclitaxel 50 mg/m(2) days 1, 8, 15 (28-day cycle × 4) followed by gefitinib; or (b) gefitinib 250?mg/day. With (a), 12 of 34 were progression-free at 6 months; median time to cancer progression was 3.9 months. With (b), the same occurred in 11 of 28 patients with the latter being 4.9 months. The most common reason for conventional chemotherapy was oncologists' opinion that the cancer was aggressive, and for gefitinib alone, patients' reluctance to receive chemotherapy. Interestingly, age had no influence.