Previous Maintenance Treatment Research Articles

Efficacy of Pemetrexed as Second-Line Therapy in Advanced NSCLC after Either Treatment-Free Interval or Maintenance Therapy with Gemcitabine or Erlotinib in IFCT-GFPC 05-02 Phase III Study

Maintenance therapy in advanced non-small-cell lung cancer (NSCLC) might lead to resistance to subsequent treatments. IFCT-GFPC 0502 study showed a progression-free survival (PFS) benefit with gemcitabine or erlotinib maintenance compared with observation after cisplatin-gemcitabine chemotherapy. The trial included a pre-defined pemetrexed second-line therapy, allowing post-hoc assessment of its efficacy according to previous maintenance treatment or treatment-free interval. Stage IIIB/IV NSCLC patients were randomized after four cycles of cisplatin-gemcitabine chemotherapy to either observation or to receive maintenance therapy with gemcitabine or erlotinib. Pemetrexed was given as second-line treatment on disease progression in all arms. PFS and overall survival (OS) were assessed from the beginning of pemetrexed therapy according to randomization arm. Of the 464 randomized patients, 360 (78 %) received second-line pemetrexed (130 [84%], 114 [74%], and 116 [75%] in observation, gemcitabine, and erlotinib arm, respectively). Median number of pemetrexed cycles was 3 (1-40) in all arms. Median PFS did not differ between gemcitabine and observation arms (4.2 versus 3.9 months, hazard ratio [HR] [95% confidence interval [CI] 0.81 [0.62-1.06]) or between erlotinib and observation arms (4.2 versus 3.9 months, HR 0.83 [0.64-1.09]). OS data showed a non-significant improvement with gemcitabine arm versus observation arm (8.3 versus 7.5 months, HR 0.81 [0.61-1.07]) or erlotinib arm versus observation arm (9.1 versus 7.5 months, HR 0.80 [0.61-1.05]). Results were similar for non-squamous patients. Grade 3 to 4 treatment-related adverse events (AEs) were comparable in all arms. Maintenance therapy with gemcitabine continuation or erlotinib does not seem to impair efficacy of second-line pemetrexed comparatively to administration after a treatment-free interval.

THU0324 Rituximab for severe disease flares in childhood ANCA vasculitides

BackgroundChildren with ANCA vasculitides frequently present with life-threatening organ manifestations including alveolar hemorrhage, critical subglottic stenosis and renal failure due to rapidly progressive glomerulonephritis (GN). The current initial management for...

Efficacy of pemetrexed as second-line therapy in advanced NSCLC after either treatment-free interval or maintenance therapy with gemcitabine or erlotinib in IFCT-GFPC 05-02 phase III study.

7574 Background: Continuous exposure of tumor cells to maintenance therapy in advanced NSCLC might lead to resistance to subsequent treatments. IFCT–GFPC 0502 study showed a progression-free survival (PFS) benefit with gemcitabine (G) or erlotinib (E) maintenance compared to observation (O) after cisplatin-G induction chemotherapy. The trial included a pre-defined second-line therapy with pemetrexed (P), allowing post-hoc assessment of its efficacy according to previous maintenance treatment or treatment-free interval. Methods: Stage IIIB/IV NSCLC patients (pts) with a PS of 0-1 were randomized after 4 cycles of cisplatin-G chemotherapy to O or to receive maintenance therapy with G or E until disease progression. P was given as second-line treatment on disease progression in all arms. PFS and OS were assessed from the beginning of P therapy according to randomization arm. Tumor response to P and tolerance were also analyzed. Results: Of the 464 pts randomized to either O (155), G (154) or E (155), 360 pts (78 %) received P as second-line therapy, i.e. 130 (84%), 114 (74%) and 116 (75%) in O, G and E arm, respectively. Baseline characteristics remained well balanced between arms (overall median age of 58 years, 28% female, 91% stage IV, 41% PS 0, 65/19/16%, adenocarcinoma/squamous/other, 10% non-smokers and 56% responders to induction CT). Median number of delivered P cycles was 3 (1-40) in all arms. Response rate was 19%, 7% and 15% for non-squamous pts in O, G and E, respectively. Median PFS did not significantly differ between G and O (4.2 vs 3.9 months, HR [95% CI] 0.81 [0.62-1.06]) or E and O (4.2 vs 3.9 months, HR 0.83 [0.64-1.09]). OS data showed a non-significant improvement with G vs O (HR 0.81 [0.61-1.07]) or E vs O (HR 0.80 [0.61-1.05]), with a median of 7.5, 8.3 and 9.1 months for O, G and E, respectively. Results were similar when analysis was restricted to non-squamous pts. Grade 3-4 treatment-related AEs were similar in O (33.1%), G (31.6%) and E (25%). Conclusions: Maintenance therapy with continuation of G or switch to E does not impair the efficacy of second-line P by comparison with administration after a treatment-free interval.

Is Heroin-Assisted Treatment Effective for Patients with No Previous Maintenance Treatment? Results from a German Randomised Controlled Trial

Background/Aims: Until now, the medical prescription of diamorphine (heroin) has been suggested as suitable for patients who have failed previous maintenance treatments. The aim of this paper is to assess the effects of diamorphine on opioid-dependent patients with no previous maintenance treatment experience (NPME). Methods: The German heroin trial compared diamorphine versus methadone maintenance treatment and included 107 patients with NPME. This paper is a sub-analysis of these patients. Results: When comparing this subsample with the rest of the participants in the study, large baseline differences were found, showing a more severe drug use profile in patients with NPME. However, no differences were found in terms of treatment outcome and treatment retention. In the subsample with NPME, outcome measures on the reduction of illicit drug use were significantly better under diamorphine compared to methadone treatment, while there was no difference in health outcomes. Conclusion: Controlled studies are now necessary to examine whether diamorphine treatment could be considered as one of several options in treating severely opioid-dependent patients, regardless of previous maintenance treatment experience.

Impact of Preventive Treatment With Long-Acting β 2-Adrenergic Agonists and Inhaled Corticosteroids on the Morbidity and Mortality of Severe Asthma Exacerbations in 1543 Patients

Background and objectives Recent systematic reviews and meta-analyses examining long-acting β 2-adrenergic agonists (LABA) as maintenance treatment for asthma have shown surprisingly conflicting results. The aim of the present study was to determine the impact, in terms of efficacy and safety, of previous maintenance treatment on severe asthma exacerbations. Patients and methods We retrospectively evaluated the clinical characteristics of exacerbations experienced by 1543 patients with moderate persistent and severe persistent asthma. Drug therapy was as follows: a combination of inhaled LABAs and corticosteroids (493 patients), an inhaled corticosteroid only (456 patients), and no maintenance treatment (594 patients). Results Asthmatic patients taking LABAs did not show higher mortality, longer stay in the intensive care unit, longer hospital stay, lower pH, or worse airflow obstruction than the other 2 groups. On the contrary, they had a higher mean (SD) forced expiratory volume in 1 second at discharge (54% [16%]) than patients taking inhaled corticosteroids (48% [19%]) and patients taking no maintenance treatment (48% [20%]) ( P=.009). Patients taking no maintenance treatment also had lower mean (SD) pH values (7.37 [0.11]) than patients taking LABAs (7.39 [0.09]) and patients taking inhaled corticosteroids (7.39 [0.08]) ( P=.002), and more admissions to the intensive care unit (11.1% vs 6.5% and 7.7%; P=.002 and P=.018, respectively). Conclusions This study did not reveal higher morbidity or mortality in severe asthma exacerbations in patients with moderate persistent or severe persistent asthma who had received inhaled LABAs combined with inhaled corticosteroids. On the contrary, asthma patients who did not use maintenance treatment experienced more severe asthma exacerbations.

Impacto del tratamiento preventivo con agonistas adrenérgicos β 2 de acción larga y glucocorticoides inhalados en la morbimortalidad de 1.543 episodios de exacerbación grave de asma

Background and Objectives Recent systematic reviews and meta-analyses examining long-acting #b 2-adrenergic agonists (LABA) as maintenance treatment for asthma have shown surprisingly conflicting results. The aim of the present study was to determine the impact, in terms of efficacy and safety, of previous maintenance treatment on severe asthma exacerbations. Patients and Methods We retrospectively evaluated the clinical characteristics of exacerbations experienced by 1543 patients with moderate persistent and severe persistent asthma. Drug therapy was as follows: a combination of inhaled LABAs and corticosteroids (493 patients), an inhaled corticosteroid only (456 patients), and no maintenance treatment (594 patients). Results Asthmatic patients taking LABAs did not show higher mortality, longer stay in the intensive care unit, longer hospital stay, lower pH, or worse airflow obstruction than the other 2 groups. On the contrary, they had a higher mean (SD) forced expiratory volume in 1 second at discharge (54% [16%]) than patients taking inhaled corticosteroids (48% [19%]) and patients taking no maintenance treatment (48% [20%]) ( P=.009). Patients taking no maintenance treatment also had lower mean (SD) pH values (7.37 [0.11]) than patients taking LABAs (7.39 [0.09]) and patients taking inhaled corticosteroids (7.39 [0.08]) ( P=.002), and more admissions to the intensive care unit (11.1% vs 6.5% and 7.7%; P=.002 and P=.018, respectively). Conclusions This study did not reveal higher morbidity or mortality in severe asthma exacerbations in patients with moderate persistent or severe persistent asthma who had received inhaled LABAs combined with inhaled corticosteroids. On the contrary, asthma patients who did not use maintenance treatment experienced more severe asthma exacerbations.

How long is it advisable to prolong maintenance treatment of patients with ulcerative colitis?

How long is it advisable to prolong maintenance treatment of patients with ulcerative colitis?

A double‐blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis

Sulfasalazine is accepted therapy for active ulcerative colitis, but side-effects and intolerance are common. Balsalazide is an azo-bonded pro-drug which also releases 5-aminosalicylic acid into the colon, but uses an inert carrier molecule. To compare the safety and efficacy of sul- fasalazine, 3 g, with balsalazide, 6.75 g, in the initial daily treatment of mild to moderate ulcerative colitis. A randomized, multicentre, double-blind, parallel group study was performed, with a treatment duration of 8 weeks. Patients on previous maintenance treatment were excluded. The trial medication was the sole treatment for the colitis. Efficacy was assessed by patient diaries, symptom assessment, sigmoidoscopic appearance and histology. Fifty patients were recruited: 26 allocated to the balsalazide group and 24 to the sulfasalazine group. More patients withdrew due to adverse events in the sulfasalazine group (nine patients vs. one patient in the balsalazide group, P=0.004). Improvement occurred in both groups, with a tendency to a faster response with balsalazide. Of the patients taking balsalazide, 61% achieved clinical and sigmoidoscopic remission. Balsalazide, 6.75 g, is effective as the sole treatment for patients with mild to moderately active ulcerative colitis, with significantly fewer withdrawals due to side-effects than in a similar group of patients taking sulfasalazine, 3 g.

Management of asthma in hospital: a prospective audit.

In a prospective study of management of asthma in hospital patients with acute asthma admitted to a single hospital over a calendar year were surveyed. Altogether 157 out of 194 admissions (81%) were studied. The patients (16 of whom had been admitted twice and one three times) were interviewed at home about two weeks after discharge, and their hospital records were reviewed. When interviewed an appreciable proportion of patients said that their asthma had been poorly controlled after their discharge from the hospital: 54 reported regular sleep disturbance due to wheeze, 78 tightness of the chest in the morning, and 77 wheeze after climbing one flight of stairs. Patients had been described on admission as having had symptoms of deteriorating asthma for a median of three days. Closer questioning of 71 patients, however, elicited that 50 had had regular symptoms indicating poor control for weeks or months. Most patients did not know how their drugs worked, and many did not have an appropriate plan of action in the event of a further attack. In all the cases studied 114 patients were treated with oral corticosteroids, only 70 had had their previous maintenance treatment increased at the time of discharge, and 107 had a follow up appointment booked for an average of three and a half weeks after discharge. These findings show that undersupervision and undertreatment of patients with asthma are common and not confined to those dying of the condition.

Maintenance treatment of chronic schizophrenic patients

The clinical effect of clopenthixol decanoate has been assessed in a 5-month controlled including 21 hospitalized chronic schizophrenic patients. The ratings were done with BPRS, NOSIE 30, the two psychological tests of WAIS and Grübaum, and the rating scale of Simpson & Angus to assess extrapyramidal side effects. Clopenthixol decanoate was found an effective and long-acting antipsychotic compound with few autonomic and neurological side effects. Compared with previous maintenance treatment it also showed a positive influence on depression and facilitation of the social adaptation of the patients.

The Use of Corticosteroids in the Treatment of Acute Asthma

A study of 23 patients admitted to hospital with severe acute asthma is reported in which plasma cortisol level on admission was significantly correlated with the degree of acidaemia and pulse rate. Patients who had not previously received treatment with corticosteroids responded satisfactorily to repeated daily injections of tetracosactrin depot, the rate of improvement being comparable to that observed in other patients treated with intravenous hydrocortisone hemisuccinate. A prompt and sustained rise in plasma cortisol was also seen following tetracosactrin. The total daily dose of hydrocortisone required to achieve plasma cortisol levels above 100 mug/100 ml was less when given by continuous intravenous infusion compared with intermittent injections, and a regime of 3 mg/kg body weight every six hours by infusion appeared satisfactory. Most patients reported subjective improvement by about four hours after starting treatment but objective evidence did not appear until about six hours from the start. Measurements of FEV1 and FVC proved to be the most reliable indices of the beginning of improvement although pulse rate was the first index to show maximum improvement. Previous maintenance treatment with corticosteroids in patients with asthma did not appear materially to affect the plasma half-life of intravenous hydrocortisone (4 mgm/kg body weight) when compared with healthy subjects or other patients with asthma who had not previously been treated with corticosteroids.