Amy E. Wahlquist

Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial.

BACKGROUND Rates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts. METHODS Within a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring self-defined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment. RESULTS Compared with PQA intervention, nicotine therapy sampling was associated with a significantly higher incidence of any quit attempt (49% vs 40%; relative risk [RR], 1.2; 95% CI, 1.1-1.4) and any 24-hour quit attempt (43% vs 34%; 1.3; 1.1-1.5). Nicotine therapy sampling was marginally more likely to promote floating abstinence (19% vs 15%; RR, 1.3; 95% CI, 1.0-1.7); 6-month point prevalence abstinence rates were no different between groups (16% vs 14%; 1.2; 0.9-1.6). CONCLUSION Nicotine therapy sampling during a PQA represents a novel strategy to motivate smokers to make a quit attempt. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00706979.

A placebo-controlled trial of buspirone for the treatment of marijuana dependence.

The present study investigated the potential efficacy of buspirone for treating marijuana dependence. Participants received either buspirone (maximum 60mg/day) (n=23) or matching placebo (n=27) for 12 weeks, each in conjunction with motivational interviewing. In the modified intention-to-treat analysis, the percentage of negative UDS results in the buspirone-treatment group was 18 percentage points higher than the placebo-treatment group (95% CI: -2% to 37%, p=0.071). On self-report, participants receiving buspirone reported not using marijuana 45.2% of days and participants receiving placebo reported not using 51.4% of days (p=0.55). An analysis of participants that completed the 12-week trial showed a significant difference in the percentage negative UDS (95% CI: 7-63%, p=0.014) and a trend for participants randomized to the buspirone-treatment group who completed treatment to achieve the first negative UDS result sooner than those participants treated with placebo (p=0.054). Further study with buspirone in this population may be warranted; however, strategies to enhance study retention and improve outcome measurement should be considered in future trials.

Trends in survival of patients with Burkitt lymphoma/leukemia in the USA: an analysis of 3691 cases

It is unknown whether the high rates of cure reported for Burkitt lymphoma/leukemia (BL) patients treated with chemoimmunotherapy can be verified outside published series and clinical trials. We used the Surveillance Epidemiology and End Results (SEER) database to describe time trends in outcomes of BL in the United States. Cases were divided into 2 eras based on year of diagnosis, reflecting improvements in HIV management, BL treatment, and supportive care. There was a marked improvement in survival among BL cases diagnosed in the 2002-2008 era (n = 1922) relative to 1973-2001 (n = 1769) with 5-year relative survival estimates of 56% and 43%, respectively (P < .001). Five-year relative survival improved from 71% to 87% for ages 0 to 19 (n = 970), 35% to 60% for ages 20 to 39 (n = 897), 28% to 48% for ages 40 to 59 (n = 1047), and from 25% to 33% for ages ≥60 (n = 777). In multivariable analysis, the 2002-2008 era (HR = 0.76, P < .001) was associated with lower mortality. Conversely, older age, black race, and advanced stage were associated with higher mortality. More effective therapies are needed for older patients with BL, along with improved access to modern therapy for younger patients.

Outcomes in Women Treated With MammoSite Brachytherapy or Whole Breast Irradiation Stratified by ASTRO Accelerated Partial Breast Irradiation Consensus Statement Groups

PURPOSE The American Society for Radiation Oncology published a Consensus Statement for accelerated partial breast irradiation identifying three groups: Suitable, Cautionary, and Unsuitable. The objective of this study was to compare oncologic outcomes in women treated with MammoSite brachytherapy (MB) vs. whole breast irradiation (WBI) after stratification into Statement groups. METHODS Eligible women had invasive carcinoma or ductal carcinoma in situ (DCIS) ≤ 3 cm, and ≤ 3 lymph nodes positive. Women were stratified by radiation modality and Statement groups. Survival analysis methods including Kaplan-Meier estimation, Cox regression, and competing risks analysis were used to assess overall survival (OS), disease-free survival (DFS), time to local failure (TTLF), and tumor bed failure (TBF). RESULTS A total of 459 (183 MB and 276 WBI) patients were treated from 2002 to 2009. After a median follow-up of 45 months, we found no statistical differences by stratification group or radiation modality with regard to OS and DFS. At 4 years TTLF or TBF were not statistically different between the cohorts. Univariate analysis in the MB cohort revealed that nodal positivity (pN1 vs. pN0) was related to TTLF (hazard ratio 6.39, p = 0.02). There was a suggestion that DCIS histology had an increased risk of failure when compared with invasive ductal carcinoma (hazard ratio 3.57, p = 0.06). CONCLUSIONS MB and WBI patients stratified by Statement groups seem to combine women who will have similar outcomes regardless of radiation modality. Although outcomes were similar, we remain guarded in overinterpretation of these preliminary results until further analysis and long-term follow-up data become available. Caution should be used in treating women with DCIS or pN1 disease with MB.

TOXICITY AND SURVIVAL OUTCOMES OF HYPERFRACTIONATED SPLIT-COURSE REIRRADIATION AND DAILY CONCURRENT CHEMOTHERAPY IN LOCOREGIONALLY RECURRENT, PREVIOUSLY IRRADIATED HEAD AND NECK CANCERS

Reirradiation of locoregionally recurrent, previously irradiated head/neck cancer may be considered in situations of unresectability, medical inoperability, or adverse pathologic features found at salvage resection.

Cisplatin/Irinotecan Versus Carboplatin/Paclitaxel as Definitive Chemoradiotherapy for Locoregionally Advanced Esophageal Cancer

Objective:To compare toxicities, disease control, and survival outcomes for patients treated with either cisplatin/irinotecan versus carboplatin/paclitaxel concurrent chemoradiotherapy for locally advanced esophageal cancer. Methods:Single-institution retrospective comparison between treatment groups: the cisplatin/irinotecan group was treated with 2 cycles of induction chemotherapy followed by concurrent chemoradiotherapy, whereas the carboplatin/paclitaxel group began with chemoradiotherapy followed by 2 additional cycles of chemotherapy. Acute toxicities, response rates, disease control, survival outcomes, and patterns of failure were compared between the groups. Results:Between January 2000 and December 2007, 57 patients were identified for inclusion in the present study (38 cisplatin/irinotecan and 19 carboplatin/paclitaxel). Groups were well-balanced by clinical-, pathologic-, staging-, and treatment-related factors. Thirty-five patients (92%) in the cisplatin/irinotecan group and 18 patients (95%) in the carboplatin/paclitaxel group completed the concurrent phase of chemoradiotherapy. There were no significant differences in hematologic or nonhematologic toxicities between the groups. At a median survivor follow-up of 37.6 months (range: 7.3–59.3 months) for the entire population, 22 patients were alive (16 without evidence of disease). The 3-year overall survival estimates was 19.7% for the cisplatin/irinotecan group versus 56.1% for the carboplatin/paclitaxel group (P = 0.022). Estimated 3-year cancer-specific survivals were 24.6% for the cisplatin/irinotecan group versus 59.3% for the carboplatin/paclitaxel group (P = 0.033). Conclusion:Concurrent chemoradiotherapy with carboplatin/paclitaxel is well-tolerated and provided superior overall and disease-specific survival compared with cisplatin/irinotecan chemoradiotherapy in the present study population. Further investigation is warranted.

Evaluating the Effect of Access to Free Medication to Quit Smoking: A Clinical Trial Testing the Role of Motivation

INTRODUCTION Although the majority of smokers are ambivalent about quitting, few treatments specifically target smokers lacking motivation to quit in the near future. Most existing interventions are instead predicated on the belief that active treatments should only be distributed to smokers interested in quitting, a largely untested assumption. METHODS In the current clinical trial (N = 157), motivated smokers wanting to quit in the next 30 days were given a 2-week nicotine replacement therapy (NRT) sample and a referral to a quitline (Group MNQ), while unmotivated smokers were randomized to receive the same treatment (Group UNQ) or a quitline referral only (Group UQ). Participants were tracked via telephone for 3 months to assess quitting behaviors and smoking reduction. RESULTS Groups significantly differed across all comparisons with regard to incidence of any quit attempt (MNQ: 77%, UNQ: 40%, UQ: 18%, p < .05) and any 24-hr quit attempts (62%, 32%, 16%, p < .05). Clinically meaningful differences emerged in the rates of floating (19%, 17%, 6%) and point prevalence abstinence (17%, 15%, 5%). Compared to participants in Group UQ (11%), a greater proportion of participants in Group MNQ (48%, p = .01) and Group UNQ (31%, p = .01) reduced their daily cigarette consumption by at least half. Proxy measures of cessation readiness (e.g., motivation) favored participants receiving active forms of treatment. CONCLUSIONS Providing NRT samples engaged both motivated and unmotivated smokers into the quitting process and produced positive changes in smoking outcomes. This suggests that motivation should not be considered a necessary precondition to receiving treatment.

ADJUVANT RADIOTHERAPY AND LYMPH NODE STATUS FOR PANCREATIC CANCER: RESULTS OF A STUDY FROM THE SURVEILLANCE, EPIDEMIOLOGY, AND END RESULTS (SEER) REGISTRY DATA

Objectives:This study explores the relationship of lymph node ratio (LNR) and radiotherapy (RT) to overall survival (OS) for patients with resected pancreatic cancer. The impact of adjuvant RT, number of lymph nodes (LN) resected, positive LN resected, and disease extension was also evaluated. Methods:The SEER database from 1998 to 2006 was reviewed, and 3314 patients with nonmetastatic carcinoma of the pancreas, surgical resection, examination of the regional LN, and a survival of >2 months were identified. Of these, 1597 patients received RT. Cox proportional hazards regression models and the logrank test were used to determine whether specific variables were related to OS. Results:Median OS for patients having surgery alone was 14 months (1-y survival 58.1%, 2-y survival 33.6%) and for patients having adjuvant RT was 19 months (1-y survival 73.5%, 2-y survival 41.4%), P<0.001. For patients with LNR of 0%, OS was better compared with patients with any LN involvement, regardless of treatment group. Multivariable analysis found OS significantly related to LNR, total LN resected, positive resected LN, year of diagnosis, and regional extent of disease in patients without adjuvant RT. In patients who received adjuvant RT, OS significance was only persistent for LNR, the total LN resected, and positive resected LN. Conclusions:A higher LNR was indicative of worse OS in all patients. A strong association with improvement in OS was seen in patients having received adjuvant RT.

Assessing an intervention to improve clinical trial perceptions among predominately African-American communities in South Carolina.

Background: African Americans (AA) are not well-represented in cancer clinical trials despite having significantly higher cancer mortality rates than their European-American (EA) counterparts.Objectives: The purpose of this study was to evaluate a program to improve perceptions of cancer clinical trials among AA.Methods: The program was conducted in a convenience sample of 195 participants (75.4% AA) who lived in counties with high racial disparities in cancer mortality rates and who were recruited by community partners. The 30-minute program, part of a larger 3.5-hour cancer education program, was developed by the National Institutes of Health (NIH)/National Cancer Institute (NCI). It was modified to include additional pictures of AA, AA-specific cancer mortality data, and information about the Tuskegee Syphilis Study and the resulting improved participant protection measures.Measures: The seven-item Attitudes to Randomized Trial Questionnaire (ARTQ) was used to evaluate changes in trial perceptions from pre- to posttest. Additional survey items assessed general demographic characteristics.Results: Slightly more than half of the participants had at least a college diploma (54.4%), 45.1% were married/living as married, 53.3% were female, and 45.6% had an annual household income of less than

Factors associated with severe acute esophagitis from hyperfractionated radiotherapy with concurrent chemotherapy for limited-stage small-cell lung cancer.

40,000. For each ARTQ item, most participants who had less favorable perceptions of trials at pretest changed to more positive perceptions at posttest (p < .001).Conclusions: Providing cancer clinical trial information led to more positive perceptions of cancer clinical trials. In future studies, the program could be used to help potential trial participants make informed decisions about participation; trial enrollment rates could then be evaluated.