Background. Transcutaneous monitoring of oxygen and carbon dioxide tension emerged decades ago as reliable, indirect measurements of arterial pressure of oxygen and carbon dioxide in neonates. Investigators have since found other valuable roles for this modality, particularly in critically ill adults. This investigation was undertaken to further characterize these measurements in normal and in obese adults, who are contributing to a rising proportion of intensive care unit admissions.Materials and methods. Transcutaneous sensors were adjusted for barometric pressure and calibrated to reference gases. The following were measured: equilibration time; oxygen saturation; transcutaneous oxygen tension; and transcutaneous carbon dioxide tension on room air and after administering fraction of inspired oxygen of 1.0 for 5 min (Oxygen Challenge Test).Results. One hundred three healthy and 47 obese subjects were enrolled. Oxygen Challenge Test values were 131.5 +/- 57.4 and 171.6 +/- 65.9 mm Hg for obese and healthy subjects, respectively (P value < 0.001). Smoking status, respiratory rate, and transcutaneous oxygen tension on room air best predicted the Oxygen Challenge Test response. A negative correlation was found between transcutaneous oxygen on room air and the Oxygen Challenge Test versus body mass index (P < 0.001).Conclusions. Reference ranges were determined for transcutaneous oxygen and carbon dioxide tension and the Oxygen Challenge Test in obese and in normal, healthy subjects. Increasing body mass index was associated with a lower baseline transcutaneous oxygen tension, but it was not an independent predictor of the Oxygen Challenge Test response in multivariate analysis. (C) 2008 Elsevier Inc. All rights reserved.

Objective. Despite the improvement in progression-free and overall Survival in patients with advanced ovarian cancer associated with platinum-taxane chemotherapy, strategies are needed to prevent the greater than 70% recurrence rate.Method. The Southwest Oncology Group (SWOG) initiated a phase III intergroup trial of alpha-interferon (IFN alpha-26, Schering-Plough, Kenilworth, NJ) in weekly closes of 50 x 10(6) IU (for 6 doses) versus observation only in patients with no pathological evidence of residual disease at second-look Surgery in 1988.Results. Patient accrual was extremely slow and the trial was permanently closed in 1999 by the SWOG Data and Safety Monitoring Committee with 74 registered patients. Of these patients, 70 were evaluable for progression-free and overall Survival. There was no significant difference between the two study arms in relation to median progression-free survival (P = 0.56). The median survival duration associated with intraperitoneal alpha-interferon had not been reached versus 87 months on the observation arm. In general, intraperitoneal alpha-interferon vas well tolerated. There were no treatment-related deaths or grade 4 adverse events. Although no efficacy conclusions can be drawn from this prematurely Closed trial, it should be noted that 57% of the patients on the observation arm recurred and all died, whereas 63% recurred and only 43% died on the intraperitoneal alpha-interferon arm.Conclusion. Although this was a negative Study, there should Continue to be interest in the use of biological therapy to improve survival of patients in complete remission following primary chemotherapy. (c) 2005 Elsevier Inc. All rights reserved.

Objectives. To evaluate the response rate and progression free and overall survival of patients with advanced endometrial cancer treated with paclitaxel, carboplatin and amifostine. To evaluate the toxicity of amifostine when used in combination with carboplatin and paclitaxel.Methods. Forty-seven eligible patients (median age: 66; range 45-82) with bidimensionally measurable advanced, recurrent, or refractory endometrial cancer were treated with carboplatin (AUC = 6), paclitaxel (175 mg/M2) and amifostine (740 mg/M2) every 4 weeks for 6 cycles or until disease progression or unacceptable toxicity.Results. There were 4 CRs (8%) (2 confirmed, 2 unconfirmed) and 15 PRs (32%) (1) confirmed, 6 unconfirmed) for a total response rate of 40% (95% confidence interval [CI], 26% to 56%). The median progression-free survival (PFS) was 7 months (95% Cl, 6-9 months) and a 6-month PFS rate of 64% (95% Cl, 50% to 78%). The median overall survival was 14 months (95% Cl, 12 to 17 months). Toxicity was tolerable. While 79% of patients developed Grade 3/4 neutropenia, (30% Grade 3, 49% Grade 4), there were no episodes of Grade 4 febrile neutropenia and one episode of infection with grades 3-4 neutropenia.Conclusion. The combination of paclitaxel and carboplatin with amifostine was well reasonably tolerated in this cohort. The regimen demonstrated significant activity in endometrial cancer, comparable to other multi-agent chemotherapy programs in terms of response rate and survival, and with a favorable toxicity profile. (c) 2004 Elsevier Inc. All rights reserved.

Howman, Sonia; Minuto, Michael; Jiang, Caroline; Gallacher, Scott; Terminella, Luigi; Ishizaki, Richard; Barnett, V Theodore Author Information

Objective This report provides follow-up progression-free survival (PFS) and median survival data for women who achieved clinical complete remission (cCR) from stage III ovarian cancer after first-line therapy and were treated with altretamine consolidation therapy. Methods Patients who enrolled in the SWOG 9326 study from September 1993 to July 1997 were required to have documented cCR from stage III ovarian cancer following front-line platinum-based therapy. Treatment consisted of 6 months of oral altretamine at 260 mg/m2/day for 14 consecutive days of a 28-day cycle. Results Ninety-seven of 112 enrolled patients were evaluable for efficacy. This report presents median 6.2-year follow-up, dating from study registration. Median PFS was 28 (95% CI: 19–43) months. Median PFS for patients with optimal disease was 45 (95% CI: 27–48) months and for patients with suboptimal disease was 17 (95% CI: 12–26) months. Twenty-six of 61 (43%) patients with optimally debulked lesions and 5 of 36 (14%) patients with suboptimally debulked lesions remained disease free. Median survival of patients with optimally debulked disease has not been reached; median survival of patients with suboptimally debulked disease was 39 (95% CI: 19–51) months. No treatment-related adverse events were reported during the follow-up period. Conclusions Consolidation therapy with oral altretamine was generally well tolerated and associated with prolonged progression-free and overall survival in the Phase II setting.

Objective. The survival of cervix cancer patients is associated with their hemoglobin (Hgb) level during radiotherapy. The Southwest Oncology Group (SWOG) conducted a phase II trial to determine whether recombinant human erythropoietin (rHuEPO) safely corrects anemia during chemoradiotherapy for cervix cancer.Methods. Patients had stage IIB-IVA cervix cancer and a Hgb between 8.0 and 12.5 g/dl. All patients received rHuEPO thrice weekly and oral iron starting 10-15 days before their 5-week course of whole pelvic irradiation and weekly cisplatin followed by intracavitary brachytherapy.Results. Fifty-three patients from 26 institutions received the protocol treatment. The mean Hgb was 10.4+/-1.3 g/dl on the first day of rHuEPO administration (baseline), 11.0+/-1.6 g/dl on the first day of chemoradiotherapy, 11.6+/-1.9 g/dl at the midpoint of chemoradiotherapy, and 11.8+/-2.2 g/dl at the end of chemoradiotherapy. The target Hgb level of 12.5 g/dl was achieved in 40% of patients (95% CI 26-56%) by the midpoint of chemoradiotherapy. Change in Hgb was associated with baseline serum iron (P=0.008) and transferrin saturation (P=0.05) levels, but not with baseline Hgb or serum ferritin, or patient age. Seven patients developed deep vein thrombosis. Two-year progression-free survival (PFS) was 43% and overall survival (OS) was 51%. Survival was significantly associated with Hgb level at the end of chemoradiotherapy, but not with the baseline Hgb level.Conclusions. rHuEPO and iron gradually increased Hgb levels in anemic women with local advanced cervix cancer during chemoradiotherapy. There was a higher than expected incidence of deep vein thrombosis. The progression-free and overall survival rates were lower than reported for women with normal Hgb levels. (C) 2004 Elsevier Inc. All rights reserved.

PURPOSE:To determine whether continuing paclitaxel for an extended time period in women with advanced ovarian cancer who had achieved a clinically defined complete response to a platinum/paclitaxel-based chemotherapy could prolong subsequent progression-free survival (PFS) and affect ultimate survival.PATIENTS AND METHODS:Patients were randomly assigned to either three or 12 cycles of single-agent paclitaxel administered every 28 days and were then followed up for progression-free and overall survival.RESULTS:As of September 6, 2001, 277 patients (262 assessable) had entered the trial, with a total of 54 PFS events having developed among 222 patients with follow-up data. With the exception of peripheral neuropathy, there were no major differences in toxicity between the regimens. The median PFS was 21 and 28 months in the three-cycle and 12-cycle paclitaxel arms, respectively. One-sided P values from an unadjusted log-rank test and an adjusted Cox model analysis (for stratification factors) were.0035 and.0023, respectively, both in favor of the 12-cycle arm. The Cox model-adjusted three-cycle versus the 12-cycle progression hazard ratio was estimated to be 2.31 (99% confidence interval, 1.08 to 4.94). With a protocol-specified early termination boundary of P =.005, these findings led the Southwest Oncology Group Data Safety Monitoring Committee to discontinue the trial. As of the date of study closure, there was no difference in overall survival between the treatment arms.CONCLUSION:Twelve cycles of single-agent paclitaxel administered to women with advanced ovarian cancer who attain a clinically defined complete response to initial platinum/paclitaxel-based chemotherapy significantly prolongs the duration of PFS.

PURPOSE The median survival time for women with optimally debulked adenocarcinoma of the ovary treated with intravenous (IV) chemotherapy is 41 to 52 months, and the 2-year survival rate is 65% to 70%. Recent studies evaluating intraperitoneal (IP) chemotherapy have reported a median survival time of 49 to 63 months and 2-year survival rates of 70% to 80%. This phase II trial was undertaken to evaluate the feasibility of and 2-year survival rate achieved by the combination of IP paclitaxel, IP cisplatin, and IV paclitaxel in women with optimally debulked, stage III ovarian cancer. PATIENTS AND METHODS Treatment consisted of paclitaxel 135 mg/m(2) IV over 24 hours on days 1 to 2, cisplatin 100 mg/m(2) IP on day 2, and paclitaxel 60 mg/m(2) IP on day 8 administered every 21 days for six cycles. RESULTS In 68 assessable women with optimal stage III ovarian cancer, the 2-year survival rate was 91%, and the median survival time was 51 months. The 2-year disease-free survival rate was 66%, and median disease-free survival time was 33 months. Ninety-six percent of all patients experienced at least one grade 3 to 4 adverse event during therapy, with the most common events being neutropenia (79%), nausea (50%), vomiting (34%), and fatigue/malaise/lethargy (24%). Seventy-one percent of patients completed all six cycles of IV/IP therapy as planned. CONCLUSION Combined IV and IP chemotherapy with cisplatin and paclitaxel is associated with a very promising 2-year survival rate in women with optimally debulked ovarian cancer. The ultimate impact of this approach on overall survival requires further evaluation in a randomized trial setting.