Impact Of Treatment Duration Research Articles

Randomized Trial on 14 versus 7 days of Esomeprazole, Moxifloxacin, and Amoxicillin for Second-line or Rescue Treatment of Helicobacter pylori Infection

Triple therapy with a proton pump inhibitor, moxifloxacin, and amoxicillin has been proven effective in first-line treatment of Helicobacter pylori infection. To explore 1, the value of triple therapy with esomeprazole, moxifloxacin, and amoxicillin in second-line or rescue treatment of Caucasian patients and 2, the impact of treatment duration on eradication success. H. pylori-infected patients with at least one previous treatment failure were randomized to oral esomeprazole 20 mg b.i.d., moxifloxacin 400 mg o.d., and amoxicillin 1000 mg b.i.d. for either 7 (EMA-7) or 14 days (EMA-14). Eradication was confirmed by 13C urea breath test. Antimicrobial susceptibility testing was performed in all patients at baseline and in patients who failed treatment. Eighty patients were randomized, and 60% had ≥ 2 previous treatment failures. Pretreatment resistance against clarithromycin and metronidazole was found in 70.5 and 61.5% of cases, respectively. The intention-to-treat eradication rate was significantly higher after EMA-14 compared with EMA-7 (95.0 vs 78.9%, p = .036). No independent risk factor for treatment failure could be identified. There were no serious adverse events. Five of the EMA-14 patients (12.5%) compared with none of the EMA-7 patients discontinued prematurely because of adverse events (p = .031). Post-treatment resistance against moxifloxacin was found in one of seven patients with isolated organisms (14.3%). Second-line/rescue H. pylori eradication therapy with esomeprazole, moxifloxacin, and amoxicillin is very effective and well tolerated. Fourteen days of treatment significantly increase the eradication rate but also the rate of adverse events.

Psychodynamic Group Psychotherapy: Impact of Group Length and Therapist Professional Characteristics on Development of Therapeutic Alliance

Little research has been done on therapeutic alliance in group psychotherapy, especially the impact of treatment duration and therapist professional characteristics. Therapeutic alliance was rated by patients on the Working Alliance Inventory-Short Form at three time points (sessions 3, 10 and 17) in a randomized controlled trial of short-term and long-term psychodynamic group psychotherapy. As predictors we selected therapist clinical experience and length of didactic training, which have demonstrated ambiguous results in previous research. Linear latent variable growth curve models (structural equation modeling) were developed for the three Working Alliance Inventory-Short Form subscales bond, task and goal. We found a significant variance in individual growth curves (intercepts and slopes) but no differential development due to group length. Longer therapist formal training had a negative impact on early values of subscale task in both treatments. There was an interaction between length of the therapists' clinical experience and group length on early bond, task and goal: therapists with longer clinical experience were rated lower on initial bond in the long-term group but less so in the short-term group. Longer clinical experience influenced initial task and goal positively in the short-term group but was unimportant for task or significantly negative for goal in the long-term group. There was no mean development of alliance, and group length did not differentially impact the alliance during 6 months. Early ratings of the three Working Alliance Inventory-Short Form subscales partly reflected different preparations of patients in the two group formats, partly therapist characteristics, but more research is needed to see how these aspects impact alliance development and outcome. Therapists should pay attention to all three aspects of the alliance, when they prepare patients for group therapy. In psychodynamic groups, length of therapy does not differentiate the overall level or the development of member-leader alliance. Within psychodynamic groups, each individual appear to have their unique perception of the member-leader alliance. Therapists with longer formal psychotherapy training may be less successful in establishing early agreement with patients on the tasks of psychodynamic group psychotherapy. Patients perceive a somewhat lower degree of early emotional bonding with the more clinically experienced therapists in long-term psychodynamics groups. Therapists with more clinical experience may contribute to a stronger degree of initial agreement with patients on the tasks and goals of short-term group psychotherapy.

Abstract S6-3: Four vs 6 Cycles of Doxorubicin and Cyclophosphamide (AC) or Paclitaxel (T) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Nodes: CALGB 40101 — A 2x2 Factorial Phase III Trial: First Results Comparing 4 vs 6 Cycles of Therapy

Abstract Background: Four cycles of chemotherapy are frequently used as standard adjuvant chemotherapy for patients with low-risk primary breast cancer, though other regimens such as CAF, CMF, and TAC frequently are given for 6 cycles. Using a phase 3 factorial design we attempted to define whether 6 cycles of one chemotherapy regimen are superior to 4 cycles in patients with low-risk primary breast cancer. We also sought to determine if T would be equally efficacious as compared to AC, with reduced toxicity. Methods: The study enrolled women with operable breast cancer and 0-3 positive nodes. Study stratifiers were ER/PgR, HER2, and menopausal status. When the study was activated in May 2002, AC (60 and 600 mg/m2) was administered every 3 wks for 4 or 6 cycles, and T (80mg/m2) weekly for 12 or 18 wks. In 2003 (after 570 enrolled patients) treatment schedule was changed to every 2 wks for both AC and T (175 mg/m2), each given for 4 or 6 cycles. In 2008 accrual to the 6-cycle regimens was permanently closed due to slow accrual, with 3173 patients enrolled. The primary endpoint for this comparison was the superiority of 6 vs 4 cycles in relapse-free survival (RFS). The study was powered to have 567 RFS events. Data comparing AC with T are not yet available. Results: This report describes the impact of treatment duration and includes the 3173 patients randomized to 6- versus 4-cycles of chemotherapy, 93% of whom had node-negative disease. At a median follow-up of 4.6 years (2.5 - 8 yrs), the number of RFS events is 288 (with 138 on 4 cycles vs 150 on 6 cycles). The 4-yr RFS was 91.6% and 91.8% for 6 and 4 cycles, respectively. The Hazard Ratio of 6 to 4 cycles was 1.10 (95% CI = 0.87-1.39, p=0.42). Four-year OS was 95.3% and 96.4% for 6 and 4 cycles, respectively, with a HR of 6 to 4 cycles of 1.31 (95% CI = 0.95-1.82, p=0.097). Based on the present data the Bayesian predictive probability of concluding superiority of 6 cycles [a primary goal of the study] with 567 RFS events is only 0.001. There was no interaction between the number of cycles and type of chemotherapy, ER/PgR status, or HER2 status. In particular, the effect of number of cycles on RFS and OS was similar for both AC and T. Conclusions: For women with primary breast cancer and 0-3 positive nodes, we found no evidence that extending chemotherapy from 4 to 6 cycles improves clinical outcome. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr S6-3.

Optimal duration of chemotherapy (CT) for advanced non-small cell lung cancer (NSCLC) in the first- and second-line settings

e19037 Background: No difference in efficacy has been observed between 3 or 4 vs 6 cycles of 1st line CT in patients (pts) with advanced NSCLC. Although longer treatment may improve progression-free survival, this must be weighed against increased toxicity and potential for worse quality of life. There are no prospective, randomized data on the optimal duration of 2nd line CT. The aims of this retrospective study were to (i) confirm the lack of impact of treatment duration on response rate in 1st line NSCLC and (ii) investigate the impact of treatment duration in the 2nd line setting. Methods: Eligible pts had received at least 4 cycles of 1st line (n=95) or 2nd line (n=55) CT for stage IIIB/IV NSCLC in clinical trials of the ATOM group, Udine, Italy, or the National Cancer Institute, Genoa, Italy and achieved stable disease or responded to treatment; trials included one in the elderly, and the addition of biological agents to CT. Response was assessed according to RECIST after alternate CT cycles and tumor dimensions recorded. The proportion of pts achieving a complete or partial response, as well as its timing and any subsequent tumor shrinkage, were analyzed by treatment line. Results: In the 1st line setting, 48 of 95 pts responded; they did so after 2 (29 pts, 61%), 4 (15 pts, 31%) and 6 cycles (4 pts, 8%). In these pts, 16 (55%) and 9 (41%) pts who had responded by the 2nd and 4th cycle respectively and continued on treatment showed further tumor shrinkage; the median further reduction in tumor size was 16% (range 1–52%) and 6% (range 1–11%), respectively. In the 2nd line setting, 12 of 55 pts responded; they did so after 2 (3 pts, 25%), 4 (7 pts, 58%), and 6 cycles (2 pts, 17%). One and two pts who had responded by the 2nd and 4th cycle respectively and continued on treatment showed further tumor shrinkage of 25%, 5% and 24%, respectively. Conclusions: Approximately 90% of CT-naive pts who responded did so by the 4th cycle; most such pts achieved only minor tumor reduction with further CT and did so at the likely expense of increased toxicity. In the 2nd line setting the achievement of response appeared slower. These results support the discontinuation of 1st CT after 4 cycles and suggest the same is true for 2nd line CT. No significant financial relationships to disclose.

979 Randomized Multicenter Study of Esomeprazole, Moxifloxacin and Amoxicillin for Second-Line or Rescue Treatment of Helicobacter pylori Infection – Impact of Treatment Duration

979 Randomized Multicenter Study of Esomeprazole, Moxifloxacin and Amoxicillin for Second-Line or Rescue Treatment of Helicobacter pylori Infection – Impact of Treatment Duration

Impact of Treatment Duration and Delays on In-field Disease Control for Twice-daily Radiotherapy (BID-RT) with Concurrent Chemotherapy in Limited-stage Small-cell Lung Cancer (SCLC)

Impact of Treatment Duration and Delays on In-field Disease Control for Twice-daily Radiotherapy (BID-RT) with Concurrent Chemotherapy in Limited-stage Small-cell Lung Cancer (SCLC)

Long Intraaortic Balloon Treatment Time Leads to More Vascular Complications

Intraaortic balloon counterpulsation is an established and efficient therapy. Limb ischemia is the most common complication. The impact of treatment duration on balloon-related complications was analyzed retrospectively in 135 patients who underwent balloon counterpulsation between 1998 and 2004. Thirty high-risk coronary patients required preoperative intraaortic balloon therapy, 41 were in preoperative cardiogenic shock, and 64 needed support for difficulties in weaning from cardiopulmonary bypass. No balloon-related mortality occurred. The overall balloon-related complication rate was 20/135 (14.8%); 18 had limb ischemia, of whom 6 (4.4%) required vascular interventions. Intraaortic balloon treatment time was significantly longer in patients who developed limb ischemia (99.8 +/- 54.1 h) compared to those who did not (34.4 +/- 30.4 h). Preoperative therapy had short treatment times and few complications. Intraaortic balloon pumping provides effective circulatory support with a low complication rate. A clear relationship was established between duration of treatment and balloon-related complications. Independent risk factors for balloon-related complications were long treatment time, acute myocardial infarction, age over 65 years, and ejection fraction less than 0.30.

Decreased efficacy of cyclophosphamide, epirubicin and 5-fluorouracil in metastatic breast cancer when reducing treatment duration from 18 to 6 months

The impact of treatment duration on survival and progression-free survival is uncertain in metastatic breast cancer. In this trial 359 patients were randomised to receive cyclophosphamide, epirubicin and 5-fluorouracil (CEF) once every 3 weeks for a maximum of 18 months or identical chemotherapy for a maximum of 6 months. Following progressive disease (PD) or severe toxicity CEF was discontinued before the scheduled maximum duration. A second series of CEF continued for a maximum of 12 months was offered to patients with PD more than 3 weeks after completing a maximum of 6 months of CEF. Both groups received tamoxifen (30 mg daily) until PD, and premenopausal patients also received ovarian irradiation. After 6 months 254 evaluable patients were unprogressive. Survival and progression-free survival were significantly longer in 127 patients continuing CEF than in 127 patients interrupting CEF at 6 months (chi 2 = 17.6, P = 0.00003 and chi 2 = 4.7, P = 0.03, respectively). The results of the second series of CEF were discouraging with only one complete response in 44 evaluable patients. In conclusion, prolonged chemotherapy for 18 months is superior to identical chemotherapy for 6 months in the treatment of metastatic breast cancer.