A B S T R A C T PurposeThe regimens of weekly irinotecan with platinum have been used for treatment of metastatic small-cell lung cancer (SCLC). We conducted a multi-institution phase II trial to evaluate a novel 21-day schedule of irinotecan and carboplatin in patients with relapsed or extensive SCLC. Patients and MethodsEighty patients were enrolled with the following characteristics: 39 male patients, 41 female patients; median age, 65 years; and Zubrod performance status, 0 to 1 in 85% and 2 in 15% of patients. Dosing schemas were based on the maximum-tolerated dose derived in a previous phase I study. Chemotherapy-naive patients with extensive SCLC were treated with irinotecan 200 mg/m 2 and carboplatin area under the curve (AUC) of 5 (arm A). Patients, who had previously been treated with chemotherapy and had relapsed disease received irinotecan 150 mg/m 2 and carboplatin AUC of 5 (arm B). In each study arm, the treatment was given every 21 days for up to six cycles. ResultsThe most common grade 3 to 4 toxicities included neutropenia (54%), thrombocytopenia (22%), anemia (13%), diarrhea (22%), and nausea/emesis (11%) in both study arms. There were three treatment-related deaths owing to neutropenic sepsis. Among 72 assessable patients, response rates of 65% and 50% were observed, respectively, for arm A and arm B. The median survival for both study arms was identical at 10 months (95% CI, 6 to 14 months). A response rate of 65% was observed in the intracranial disease of 14 patients with known brain metastases. ConclusionThis 21-day regimen of irinotecan and carboplatin seems promising for the treatment of relapsed SCLC.
A patient receiving capecitabine-containing chemotherapy developed persistent but reversible cerebellar ataxia.
12004 Background: The majority of head/neck (HN) patients who undergo radiotherapy develop RIX. Unfortunately, existing treatments are of limited benefit and have side effects. Initial small studies suggest acupuncture may treat chronic RIX. A multicenter, phase III, randomized, sham-controlled trial (NCT02589938) was conducted to compare true acupuncture (TA) with sham acupuncture (SA) and wait list control (WLC) group in treating chronic RIX. Methods: HN patients with chronic RIX at least 12 months post-RT were recruited through the WF NCORP RB network (2UG1CA189824). Patients must have received bilateral radiation therapy with subsequent grade 2 or 3 xerostomia per modified RTOG scale, with no history of xerostomia or other illness known to affect salivation prior to HN XRT. All patients received standard oral hygiene and were randomized to TA, SA, or WLC. Patients in TA and SA were treated 2 times per week for 4 weeks. Those experiencing a marginal response (10-19 point decrease on the Xerostomia questionnaire (XQ)) received another 4 weeks of the respective treatment. Patients who had no response (increase in XQ score or decrease of < 10 points from baseline), partial response (20 or more point decrease in XQ score from baseline), or complete response (XQ score = 0) did not receive further treatment. Patient outcomes including XQ and FACT-HN were collected at baseline, 4, 8, and 12 weeks; the primary endpoint was XQ at 4 weeks. A sample size of 80 per group (240 total), had 80% power to detect a difference of 10 points between groups, assuming two-sided alpha = 0.013 and 20% attrition. Analysis of covariance adjusted for baseline XQ and Bonferroni corrections for pairwise comparisons. Results: 258 from 33 different practices participated. Average age was 65 years, 78% male, and 67% had AJCC stage IV a,b disease. At week 4, there was a group main effect on the XQ (P = 0.02) revealing significant between group differences between TA and WLC (51.1 vs 56.8, P = 0.008), with marginal between group difference between TA and SA (51.1 vs 54.5, P = 0.066) and no difference between SA and WLC (P = 0.36). A similar pattern was seen at week 8 (TA = 48.3, SA = 50.8, WLC = 54.8; only TA vs WLC significant, P = 0.012) and 12 (TA = 48.6, SA = 49.3.8, WLC = 54.6; TA vs WLC, P = 0.02; SA vs WLC, P = 0.04; TA vs SA, P = 0.79). Incidence of clinically significant RIX (XQ scores > 30) followed a similar pattern. The FACT-HN at week 12 revealed statistically and clinically significant group differences for the total score and several subscales between TA vs SA and WLC with no differences between SA and WLC. Completer and mediation analyses will be presented. Conclusions: True acupuncture was more effective in treating chronic RIX and improving QOL one or more years after the end of XRT than sham acupuncture or standard oral hygiene. Clinical trial information: NCT02589938.
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