scholarly journals Low Dose Theophylline and Tiotropium Rotacap as Add on Therapy in COPD Patients-Clinical Trial

2021 ◽  
Vol 10 (02) ◽  
pp. 137-141
Author(s):  
Muzna Hameed Dar ◽  
Syed Mehboob Alam ◽  
Qurrat ul Ain Bukhari ◽  
Kauser Ismail ◽  
Syed Azhar Hussain Zaidi
Keyword(s):  
Clinical Trial ◽  
Low Dose ◽  
Therapy Group ◽  
Treated Group ◽  
Open Label ◽  
Treatment Groups ◽  
Copd Patients ◽  
Percentage Improvement ◽  
Significant Difference ◽  
Group B

Objectives: To compare the role of low dose Theophylline and Tiotropium rotacap in improving the lung functions and day to day life of patients suffering from COPD. Study Design and Setting: A Clinical trial study was conducted at Department of Pharmacology and Therapeutics, BMSI in association with Department of Chest Medicine, JPMC. Methodology: This study was planned as an open label and parallel clinical trial study. A total of 168 patients of COPD were selected for this study and only 161 patients completed the 3 months duration of the study. The enrolled patients were grouped into 2, namely A and B. Tab. Theophylline 350 mg was given to Group A in two divided doses while Tiotropium rotacap18µg through rotahaler was given to group B once a day. Results: Mean FEV1 ± SD was improved by 0.04 ± 0.02 in Theophylline therapy group while by 0.07 ± 0.01 in the Tiotropium therapy treated group and a significant difference between the changes in the two treatment groups was evident. There was a percentage improvement in PEFR of 8.9 ± 5.8 in the Theophylline therapy treated group and of 13.2 ± 4.7 in Tiotropium therapy treated group. When Tiotropium group was compared with Theophylline group for improvement in percentage change in PEFR from day 0, a significant difference was evident between the two groups. There was a significant improvement from day 0 in CAT score in Tiotropium treated groups versus Theophylline group after 3 months of therapy. Conclusion: Tiotropium rotacap was more effective as compared to low dose Theophylline in improving pulmonary functions and CAT score in patients with COPD

scholarly journals Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Francisco Baccaro
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Vaginal Stenosis ◽  
Significant Difference ◽  
Vaginal Dilators ◽  
The Mean ◽  
Topical Estrogen

Abstract Background We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18–75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). Conclusions there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. Trial registration Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered.

scholarly journals Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0244500
Author(s):  
Antonio Mestrovic ◽  
Nikola Perkovic ◽  
Josko Bozic ◽  
Mirela Pavicic Ivelja ◽  
Jonatan Vukovic ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Adverse Events ◽  
Therapy Group ◽  
Compliance Rate ◽  
Randomised Clinical Trial ◽  
First Line ◽  
Open Label ◽  
Hybrid Therapy ◽  
Significant Difference

Background The primary objective of this study was to compare concomitant and hybrid therapy in the first line eradication treatment of Helicobacter pylori infection in Split-Dalmatia County, Croatia, in which clarithromycin resistance is above 20%. The secondary objective of the study was to determine and compare compliance and adverse events rate between these therapeutic protocols. Materials and methods In an open-label, randomised clinical trial 140 patients total with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 g, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or hybrid (esomeprazole 40 mg and amoxicillin 1 g twice daily during 14 days with adding metronidazole 500 mg and clarithromycin 500 mg twice daily, in the last 7 days,) treatment group. Results Eradication rates for concomitant group and hybrid therapy group were 84.1% (58/69) and 83.1% (59/71) respectively in the intention-to-treat analysis and 96.7% (58/60) and 95.2% (59/62) in per-protocol analysis. There was no significant difference between the groups (ITT analysis: P = 0.878; PP analysis: P = 0.675). Adverse events were more frequent in the concomitant group (33.3% vs 18.3%, P = 0.043). There was no difference among groups regarding compliance rate. Conclusion Hybrid therapy has similar eradication rate as concomitant therapy, with lower adverse events rate. In the era of increasing antibiotic resistance, eradication regime with less antibiotic’s usage, as hybrid therapy, should be reasonable first line treatment choice for H. pylori infection. Clinical Trials, gov: NCT03572777.

scholarly journals SUBCHRONIC TOXICITY TEST OF COMBINATION ETHANOL EXTRACT OF DETAM 1 SOYBEAN (GLYCINE MAX L. MERR) AND JATI BELANDA (GUAZUMA ULMIFOLIA LAMK) TOWARD FUNCTION, WEIGHT, AND HISTOPATHOLOGICAL OF WISTAR RAT LIVER

2016 ◽  
Vol 9 (5) ◽  
pp. 197
Author(s):  
Meilinah Hidayat ◽  
Sijani Prahastuti ◽  
Estherolita Dewi ◽  
Dewi Safitri ◽  
Siti Farah Rahmawati ◽  
...  
Keyword(s):  
Liver Function ◽  
Toxicity Test ◽  
Low Dose ◽  
Ethanol Extract ◽  
Good Effect ◽  
Control Group ◽  
High Dose ◽  
Subchronic Toxicity ◽  
Treatment Groups ◽  
Significant Difference

ABSTRACTObjective: As an antiobesity therapy, combination extracts of Detam 1 soybean and Jati Belanda will be consumed for a long time; therefore, theirtoxicities to the liver need to be investigated. To determine the effect of subchronic toxicity test of combination of ethanol extract of Detam 1 soybean(EEDS) and ethanol extract of Jati Belanda (EEJB) on liver function with parameters: Alanine transaminase (ALT), macroscopic, and histopathologicalof liver.Methods: This study was conducted on 120 Wistar rats (60 males and 60 females), 90 days (treatment group) and 120 days (satellite group). Ratswere divided into six treatment groups (3 test materials, 1 control, and 2 satellites); each group included 10 males and 10 females.Results: ALT levels of treatment groups (low dose, medium, and high), both males and females were lower than the control group (p<0.05). Thetreatment groups demonstrated a good effects effect on liver function. Liver weight of all groups showed no significant difference compared with thecontrol group (p>0.05). Results of histopathological score interpretation of male and female liver rats of low dose groups were not disturbed; middledose groups were slightly disturbed and high dose groups were damaged. Satellite high doses of male groups were disrupted, while female groupswere not.Conclusion: The combination of EEDS and EEJB has a good effect on liver function, did not lead to change organ weight and at low doses did not causerenal histopathology damage in rats after 90 days administration.Keywords: Combination of soybean Jati Belanda, Toxicity subchronic test, Function, Weight, Histopathology, Liver.

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

scholarly journals Topiramate Versus Propranolol in the Prophylaxis of Migraine in Bangladeshi Population

2020 ◽  
Vol 18 (2) ◽  
pp. 12-17
Author(s):  
Muhammad Tayeb ◽  
Md Hasanuzzaman ◽  
Abul Mansur Md Rezaul Karim ◽  
Mohammad Sanaullah ◽  
Md Ashraful Islam
Keyword(s):  
Migraine Attack ◽  
Divided Dose ◽  
Low Dose ◽  
Primary Headache ◽  
Headache Disorder ◽  
Treatment Groups ◽  
Primary Headache Disorder ◽  
Significant Difference ◽  
The Mean ◽  
Bangladeshi Population

Background : Migraine is primary headache disorder characterized by recurring attacks of pain and associated symptoms. The management modality is still unsatisfactory due to poor understanding of its cause and pathogenesis. To assess the efficacy and safety of low dose Topiramate vs Propranolol in migraine prophylaxis. Materials and methods : A randomized clinical trial including 130 patients with frequent migraine headache >5 attacks per month was performed in the out patients Department of Medicine and Neurology, CMCH for a period of 12 weeks. The patients were randomly divided into two treatment groups – treated by Topiramate 50mg/day and Propranolol 80mg/day respectively. Topiramate started with 25mg/day for 7 days then increased up to 50mg/day in two divided dose. Propranolol started with 40mg/day for 7 days then increased up to 80mg/day in two divided dose. The patients were assessed at 0, 8 and 12 weeks of the study. Results: The Topiramate group showed a reduction in the mean (±SD) of frequency of migraine attack from 6.95(±2.88) to 1.75(±1.08) episode per month, headache days per month from 7.62(±4.14) to 1.83(±1.10), intensity of headache per attack from 8.98(±1.05) to 6.10(±2.50) based on VAS scale, duration of headache per episode from 11.56(±9.16) to 5.40(±2.97) per hour and MIDAS score from 16.19(±3.91) to 8.14(±3.93). In patient treated with Propranolol, the mean (±SD) of monthly frequency of migraine attack declined from 7.09(±2.87) to 1.92(±0.98) episode per month, headache days per month from 8.17(±4.52) to 1.86(±o.83), intensity of headache per attack from 8.47(±1.10) to 6.03(±2.05) based on VAS scale, duration of headache per episode from 11.16(±8.08) to 5.97(±3.45), MIDAS score from 15.48(±3.55) to7.77(±3.49). Pre- and post-treatment values were significantly different for individual groups but no significant difference observed between groups. Conclusion: This study demonstrated that both low dose Topiramate and propranolol could significantly reduce migraine frequency, intensity and duration. Chatt Maa Shi Hosp Med Coll J; Vol.18 (2); July 2019; Page 12-17

A randomized, open-label, phase 3 study of low-dose selinexor and lenalidomide (Len) versus len maintenance post autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma (NDMM): ALLG MM23, Sealand.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS8055-TPS8055
Author(s):  
Hang Quach ◽  
Masa Lasica ◽  
David Routledge ◽  
Anna Kalff ◽  
Andrew Lim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nuclear Export ◽  
Low Dose ◽  
Performance Status ◽  
Cell Transplant ◽  
Weekly Schedule ◽  
Open Label ◽  
Phase 3 ◽  
Clinical Trial Registration ◽  
National Cooperative

TPS8055 Background: Len maintenance post ASCT is standard of care for patients (pts) with NDMM. Deep responses (CR or better) post ASCT correlates with better progression free survival (PFS). In a meta-analysis of len maintenance post ASCT (McCarthy PL et al. J Clin Oncol. 2017), only 10.7% of pts achieve CR post ASCT, and 72% of pts who discontinued len maintenance did so because of progressive disease (PD). Selinexor is a selective inhibitor of nuclear export that blocks exportin 1, thus retaining tumour suppressor proteins within the nucleus while blocking proto-oncoprotein translation. It is approved in combination with bortezomib and dexamethasone (dex) for pts with MM who have had at least 1 prior line of treatment, or with dex for pts with penta-refractory MM by the FDA. The oral bioavailability and weekly schedule of selinexor makes it suitable in combination with len for maintenance therapy. Given the encouraging activity (ORR 92%) and tolerability of selinexor, len and dex from the phase 1b/2 STOMP study, we hypothesise that combination low-dose selinexor and len (XR) will be well tolerated and effective, increasing CR and MRD negativity rate post ASCT, thus prolonging PFS compared to len. Methods: ALLG MM23 SeaLAND, is an ongoing randomised, multi-centre, phase 3 trial. Eligible pts ( > 17 years of age) have measurable disease, have undergone 3-6 cycles (C) of induction containing a proteasome inhibitor (PI) and/or immunomodulatory drug and recovered post melphalan-conditioned ASCT with adequate haematopoiesis, renal and liver function, and with ECOG performance status. Registration occurs prior to ASCT with screening between 75 to 115 days post ASCT. The study includes a lead-in safety phase of 20 patients with XR: Len 10mg daily days 1 to 21 and Selinexor 40mg weekly in a 28-day cycle. If well tolerated, Selinexor escalates to 60mg po weekly from C2 and Len to 15mg po daily from C4. Two safety reviews will occur after the 10th and 20th patients completes C2, respectively. Upon meeting safety criteria, a sample size of 290 pts will be randomised 1:1 to XR or lenalidomide (R). Therapy will continue until PD. The primary endpoint is PFS at 3 years post randomisation. Secondary endpoints include ORR and MRD-negativity rate (International Myeloma Working Group Response Criteria), PFS on next treatment line (PFS2), OS, safety and tolerability, quality of life, and cost effectiveness. Main analysis occurs after 232 patients complete 3-years of follow-up. Exploratory objective is to correlate immunological and molecular profiles to treatment response and resistance. ALLG MM23 SeaLAND is a multisite bi-national investigator-initiated trial lead by Australia and New Zealand’s national cooperative group, the Australasian Leukaemia & Lymphoma Group. Clinical trial registration: ACTRN12620000291987p. Clinical trial information: 12620000291987.

Intraoperative seizure outcome of levetiracetam combined with perampanel therapy in patients with glioma undergoing awake brain surgery

2021 ◽  
pp. 1-10
Author(s):  
Kazuya Motomura ◽  
Lushun Chalise ◽  
Hiroyuki Shimizu ◽  
Junya Yamaguchi ◽  
Tomohide Nishikawa ◽  
...  
Keyword(s):  
Therapy Group ◽  
Class Ii ◽  
Awake Surgery ◽  
Brain Surgery ◽  
Seizure Outcome ◽  
Logistic Regression Models ◽  
Treatment Groups ◽  
Intractable Seizures ◽  
Significant Difference ◽  
International League

OBJECTIVEThis study aimed to evaluate the efficacy of levetiracetam (LEV) combined with perampanel (PER) therapy for intraoperative seizure treatment to determine whether a combination of LEV and PER can aid in the prevention of intraoperative intractable seizures during awake surgery.METHODSThe authors performed a retrospective cohort study in 78 consecutive patients with glioma who underwent awake surgery using intraoperative direct electrical stimulation mapping. To prevent intraoperative seizures, 50 patients were treated with the antiepileptic drug LEV only (LEV group) from January 2017 to January 2019, while the remaining 28 patients were treated with LEV plus PER (LEV + PER group) between March 2019 and January 2020. LEV (1000–3000 mg) and/or PER (2–4 mg) were administered before the surgery.RESULTSPreoperative seizures with International League Against Epilepsy (ILAE) class II–VI occurred in 44% of the patients in the LEV group and in 35.7% of patients in the LEV + PER group, with no significant difference between groups (p = 0.319). Total intraoperative seizures occurred in 18 patients (36.0%) in the LEV therapy group and in 2 patients (7.1%) in the LEV + PER group (p = 0.009). Of these, there were no patients (0%) with intractable seizures in the LEV + PER group. Regarding factors that influence intraoperative seizures in glioma patients during awake brain surgery, multivariate logistic regression models revealed that the occurrence of intraoperative seizures was significantly related to the involvement of motor-related regions (positive vs negative, HR 6.98, 95% CI 1.71–28.56, p = 0.007), preoperative seizure (ILAE class II–VI vs ILAE class I, HR 4.44, 95% CI 1.22–16.11, p = 0.024), and LEV + PER group (positive vs negative, HR 0.07, 95% CI 0.01–0.44, p = 0.005). Treatment-related adverse effects were rare and mild, including sleepiness, tiredness, and dizziness in both treatment groups.CONCLUSIONSThis study demonstrates that LEV + PER therapy is significantly associated with a lower risk of intraoperative seizures compared with LEV therapy alone in patients with glioma during awake brain mapping. These findings will help neurosurgeons conduct safe and reliable awake surgeries and reduce the rate of intraoperative intractable seizures during such procedures.

scholarly journals MLTI-14. A SYSTEMATIC REVIEW OF TREATMENT PARADIGMS FOR PATIENTS WITH BREAST CANCER AND ONE OR MORE BRAIN METASTASES

2019 ◽  
Vol 1 (Supplement_1) ◽  
pp. i17-i17
Author(s):  
Yosef Ellenbogen ◽  
Karanbir Brar ◽  
Nebras Warsi ◽  
Jetan Badhiwala ◽  
Alireza Mansouri
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Adverse Events ◽  
Brain Metastases ◽  
Treatment Options ◽  
Inclusion Criteria ◽  
Open Label ◽  
Treatment Groups ◽  
Molecular Features ◽  
Significant Difference

Abstract BACKGROUND: Upwards of 50% of patients with advanced breast cancer are diagnosed with brain metastases (BM). Treatment options for these patients have been rapidly evolving due to increased understanding of the tumor pathophysiology and its genetic underpinnings. This systematic review of randomized controlled trials (RCTs) aims to clarify the evidence guiding the treatment of brain metastases from breast cancer. METHODS: MEDLINE, EMBASE, Cochrane Controlled Register of Trials, ClincialTrials.gov, and Web of Science were searched from inception to October 2018 for RCTs comparing treatments for breast cancer BM. We screened studies, extracted data, and assessed risk of bias independently and in duplicate. Outcomes assessed were overall survival (OS), progression-free survival (PFS), and adverse events (Grade 3+). RESULTS: Among 3188 abstracts, only 3 RCTs (N=412; mean sample size per group N=54.7) meeting inclusion criteria were identified. The studies were phase II or III open-label parallel superiority trials. Inclusion criteria among these trials consisted of age &gt;18 with radiologic evidence of &gt;1 BM. Exclusion criteria consisted of poor-performance functional status (ECOG &gt;2 or KPS &lt; 70). The treatment groups included whole-brain radiation therapy (WBRT) vs WBRT + Temozolomide, WBRT vs WBRT + Efaproxiral, and Afatinib vs Vinorelbine vs investigators’ choice (86% of these patients received WBRT or SRS prior to study enrolment). While two trials found no significant difference in OS, one trial found significant improvement in OS with Efaproxiral in addition to WBRT compared to WBRT alone (HR 0.52; 95%CI 0.332–0.816). No significant differences were found with PFS or rate of adverse events amongst treatment groups. CONCLUSION: Considering the high prevalence of breast cancer BM and our improved understanding of genomic/molecular features of these tumors, a greater number of RCTs dedicated at this disease are needed.

Esthetic and Clinical Performance of Implant-Supported All-Ceramic Crowns Made with Prefabricated or CAD/CAM Zirconia Abutments: A Randomized, Multicenter Clinical Trial

2016 ◽  
Vol 96 (2) ◽  
pp. 163-170 ◽  
Author(s):  
J.G. Wittneben ◽  
J. Gavric ◽  
U.C. Belser ◽  
M.M. Bornstein ◽  
T. Joda ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Performance ◽  
Multicenter Clinical Trial ◽  
Anterior Maxilla ◽  
Single Crown ◽  
Significant Difference ◽  
All Ceramic ◽  
Cad Cam ◽  
Group A ◽  
Group B

Patients’ esthetic expectations are increasing, and the options of the prosthetic pathways are currently evolving. The objective of this randomized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary all-ceramic implant crowns (ICs) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM zirconia abutments veneered with hand buildup technique. The null hypothesis was that there is no statistically significant difference between the 2 groups. Forty implants were inserted in sites 14 to 24 (FDI) in 40 patients in 2 centers, the Universities of Bern and Geneva, Switzerland. After final impression, 20 patients were randomized into group A, restored with a 1-piece screw-retained single crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique, or group B using an individualized CAD/CAM zirconia abutment (CARES abutment; Institut Straumann AG) with a hand buildup technique. At baseline, 6 mo, and 1 y clinical, esthetic and radiographic parameters were assessed. Group A exhibited 1 dropout patient and 1 failure, resulting in a survival rate of 94.7% after 1 y, in comparison to 100% for group B. No other complications occurred. Clinical parameters presented stable and healthy peri-implant soft tissues. Overall, no or only minimal crestal bone changes were observed with a mean DIB (distance from the implant shoulder to the first bone-to-implant contact) of −0.15 mm (group A) and 0.12 mm (group B) at 1 y. There were no significant differences at baseline, 6 mo, and 1 y for DIB values between the 2 groups. Pink esthetic score (PES) and white esthetic score (WES) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes. Both implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla ( ClinicalTrials.gov NCT02905838).

scholarly journals A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia

Blood ◽  
1990 ◽  
Vol 75 (7) ◽  
pp. 1422-1425 ◽  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Chronic Lymphocytic Leukemia ◽  
Randomized Clinical Trial ◽  
Survival Rates ◽  
Lymphocytic Leukemia ◽  
Cooperative Group ◽  
Survival Times ◽  
Treatment Groups ◽  
Significant Difference

Abstract In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.

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