Carboplatin and paclitaxel versus cisplatin, paclitaxel and doxorubicin for frontline chemotherapy of advanced ovarian carcinoma (AOC): A Hellenic Cooperative Oncology Group Study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5074-5074
Author(s):  
G. Aravantinos ◽  
G. Fountzilas ◽  
H. P. Kalofonos ◽  
D. V. Skarlos ◽  
P. Kosmidis ◽  
...  
Keyword(s):  
Residual Disease ◽  
Randomized Study ◽  
Stage Iv ◽  
Figo Stage ◽  
Severe Toxicity ◽  
Treatment Groups ◽  
Stage Iv Disease ◽  
Group A ◽  
Intent To Treat ◽  
Group B

5074 Background: Carboplatin combined with paclitaxel are considered treatment of choice as initial chemotherapy for AOC. We compared this combination with a regimen combining cisplatin plus paclitaxel and doxorubicin. In the pre-taxane era the addition of doxorubicin to the cisplatin-based regimens appeared to improve survival. Therefore, there was a significant interest in assessing the role of a taxane/platinum/ anthracycline combination therapy in a randomized study. Methods: Patients with AOC after the initial cytoreductive surgery were stratified according to the FIGO stage and the presence of residual disease and randomized to either 6 courses of paclitaxel 175 mg/m2 as 3h infusion plus carboplatin 7AUC (group A) or paclitaxel at the same dose plus cisplatin 75 mg/m2 plus doxorubicin 40 mg/m2 and G-CSF (Lenograsim) 0.263 mg sc from day 7 to day 11 (group B). Primary endpoint was overall survival (OS). At alpha = 5%, 400 patients were required, to detect with power of 80%, a ±15% difference to a baseline survival rate of 50% at the 3-year time point. Results: Intent to treat analysis was performed on 432 patients (group A: 210, B: 222). The treatment groups were well balanced in terms of major patient and tumor characteristics. 70% of the patients had stage III and 23% stage IV disease. Significantly more patients developed febrile neutropenia in group B (p = 0.01). No other significant differences were observed in terms of severe toxicity and no difference was found between the two groups in complete and overall response rate. With a median follow up of 44 months, median survival was 37.2 months in group A and 45.2 months in group B (p = 0.33). Conclusions: Both regimens are well tolerated and effective as first line chemotherapy of AOC. Combination of cisplatin, paclitaxel and doxorubicin does not seem to improve survival as compared with the standard carboplatin/paclitaxel regimen. No significant financial relationships to disclose.

Clinical benefits of sequential administration of docetaxel and intermittent erlotinib as a second-line therapy for advanced non-small cell lung cancer (NSCLC): A phase II randomized study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18049-e18049
Author(s):  
Francisco Aparisi ◽  
Alfredo Sanchez-Hernandez ◽  
Vicente Giner ◽  
José Muñoz-Langa ◽  
Gaspar Esquerdo ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Randomized Study ◽  
Stage Iv ◽  
Primary Objective ◽  
P Value ◽  
Sequential Administration ◽  
Group A ◽  
Group B

e18049 Background: Patients (p) with advanced NSCLC have few treatment options after progressing to 1st-line platinum doublet chemotherapy. Several preclinical and phase I studies have suggested that sequential administration of erlotinib (E) and docetaxel could avoid possible negative interactions and optimize the benefit obtained against NSCLC. This randomized phase II was designed to address the clinical benefit obtained with the use of sequential administration of docetaxel and intermittent E. Methods: 70 p with advanced NSCLC progressing to previous PDC for advanced disease were randomized (1:1): Group A (n = 34): Docetaxel 75 mg/m2 day 1 and intermittent E (day 2-16), up to 4 cycles, followed by E in monotherapy; and Group B (n = 36): E in monotherapy. Treatment was administered until unacceptable toxicity or disease progression. Primary endpoint: rate of p free of progression at 6 months; secondary endpoints: progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety. The study has completed enrolment. At the date of cut-off for this communication, data of 60 patients were available: 30 in Group A/30 in Group B. Results: Baseline characteristics: non-adenocarcinoma (60.3%), current/former smokers (95%), male (90%) and stage IV (87.9%). 6 months PFS: 13.5% in the sequential arm. PFS: 2.7 months (m) in Group A (95% CI 2.1 – 3.8) and 2 m in Group B (95% CI 1.7 – 2.4) p value 0.08. Median OS: 11.0 m (95% CI 4.5 – 13.4) in group A and 4.7m (95% CI 2.5 – 6.6) in Group B with a p value 0.02. DCR: 44.4% in the experimental group whereas in the E one was 30.8%. Adverse events (AEs), including skin rash and diarrhea, were all generally tolerable. Of interest, the low number of p developing neutropenia in the D + E arm. Conclusions: Although the primary objective has not been met, an encouraging benefit on survival has been shown in the exploratory analysis, with a median overall survival of 11 months for patients treated with the sequential regimen (p value 0.02). Final data will be presented during the meeting.

scholarly journals IRON DEFICIENCY ANEMIA

2018 ◽  
Vol 25 (04) ◽  
pp. 492-496
Author(s):  
Jawaria Khalid ◽  
Muhammed Mehboob Ahmed ◽  
Misbah Khalid ◽  
Muhammad Asghar Butt ◽  
Khalid Mahmood Akhtar
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Ferrous Sulfate ◽  
Ferrous Sulphate ◽  
Acute Infection ◽  
Randomized Study ◽  
Deficiency Anemia ◽  
Treatment Groups ◽  
Group A ◽  
Group B

Objective: To compare the efficacy of Ferrous sulfate with iron polymaltosecomplex in treatment of iron deficiency anemia in children in terms of rise in hemoglobin. Studydesign: Randomized clinical trial. Setting: Department of Paediatric Medicine Unit I AlliedHospital Faisalabad. Study duration: 6 months. Methodology: All the children of age group6 month to 12year with hemoglobin level <10g/dl, MCV<70fl corrected for age, MCHC<32%,serum ferritin<8μg/l were included. All other cases of anemia other than iron deficiency anemiasuch as thalassemia, sickle cell anemia, lead poisoning etc, patients with severe anemia(hb≤6g/dl) because they need blood transfusion to correct anemia, those with decompensatedheart failure or acute infection were excluded. After enrolment patients were randomly dividedinto two groups by lottery method. Group A, patients were given ferrous sulphate. Group B,patients were given iron polymaltose complex (IPC). Both iron preparations were given inthe dose of 5mg/kg/day of elemental iron in three divided dosage 30 minutes before meals.Patients were assessed at one month interval after the start of treatment and hemoglobin waschecked at follow up visit by taking 2cc blood. Results: Sixty children were studied. Meanage was 2.5 ± 5.1 years, range 7 months to 12 years with 32 girls, 28 boys. The patients wereevenly distributed between the two treatment groups (IPC, n = 30, 50%; ferrous sulfate, n =30, 50%). All erythrocyte-related hematologic parameters after one month treatment showed asignificant improvement from baseline with both treatments. A significant improvement in Hbwas observed after one month treatment in the IPC group 9.5 ± 1.1g/dL to 10.6 ±1.0 g/dL andthe ferrous sulfate group 9.4 ± 1.6 g/dL to 11.2 ± 0.9 g/dL which was statistically significant.Conclusion: From this randomized study, it is concluded that both ferrous sulphate and ironpolymaltose complex have equal efficacy in treatment of iron deficiency anemia

scholarly journals Application of clinical genomic sequencing among Chinese advanced cancer patients to guide precision medicine decisions

2018 ◽  
Author(s):  
Shunchang Jiao ◽  
Yuxian Bai ◽  
Chun Dai ◽  
Xiaoman Xu ◽  
Xin Cai ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Stage Iv ◽  
Genomic Sequencing ◽  
Advanced Cancer Patients ◽  
Clinical Recommendation ◽  
Stage Iv Disease ◽  
Group A ◽  
Group B ◽  
Chinese Cancer Patients ◽  
The Impact

AbstractPurposeA number of studies have suggested that high-throughput genomic analyses might improve the outcomes of cancer patients. However, whether integrative information about genomic sequencing and related clinical interpretation may benefit Chinese cancer patients with stage IV disease to date has not investigated.MethodsTargeted gene panel and whole exome of tumor/blood samples in > 1,000 Chinese cancer patients were sequenced. Then we provided patients and their oncologists with the sequencing results and a clinical recommendation roadmap based on evidence-based medicine, defined as CWES. Only patients with stage IV disease who failed the previous treatment upon receiving the CWES reports were included for analyzing the impact of CWES on clinical outcomes in 1-year follow-ups.ResultsWe identified the mutational signatures of 953 Chinese cancer patients, with some being unique. Approximately 88.6% of patients had clinically actionable somatic genomic alterations. We successfully followed up 22 stage IV patients. Of these, 11 patients treatment followed the CWES reports defined as group A. Eleven patients received the next treatment, but did not follow the CWES suggestions, and are defined as group B. The types of therapies before CWES were similar in the two groups. The median PFS of group A was 12 months and 45% patients failed this round of therapy. The median PFS of group B was 4 months and 91% of patients failed the treatment.ConclusionThe current study suggested that CWES has the potential to help explore the clinical benefits in multiple line therapies among advanced stage tumor patients.

Paclitaxel/gemcitabine versus paclitaxel/vinorelbine in advanced non-small cell lung cancer (NSCLC): A phase III randomized study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8038-8038
Author(s):  
P. A. Kosmidis ◽  
E. Timotheadou ◽  
A. Koutras ◽  
G. Pentheroudakis ◽  
C. Christodoulou ◽  
...  
Keyword(s):  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Disease Characteristics ◽  
Group A ◽  
Severe Infections ◽  
Grade 3 ◽  
Intent To Treat ◽  
Group B

8038 Background: Paclitaxel and vinorelbine (PV) have shown synergism of cytotoxic effect in vitro (Cancer Invert, 2000, 18(8): 804-5). This combination was compared prospectively to the paclitaxel/gemcitabine (PG) regimen in non-operable NSCLC. Methods: 415 stage IIIb wet and IV chemotherapy-naïve for metastatic disease patients with PS 0–1 were randomized to paclitaxel 200mg/m2 on day 1 plus either gemcitabine 1gm/m2 (Group A) or vinorelbine 25mg/m2 (Group B) on days 1 and 8 every 3 wks as first line chemotherapy. Results: A total of 398 out of 415 patients were eligible for analysis on the intent to treat basis (group A: 196, group B: 202). All patient and disease characteristics were well balanced. Overall response rate (RR) was 27% for group A and 24% for group B (P=0.57). Median progression free survival (PFS) was 5.2 months (m) (95% CI, 4.4 - 5.9) and 4.7m (95% CI, 4.1 - 5.3) for groups A and B respectively (P=0.51). Median survival (OS) was 11.5m (95% CI, 9.5 - 12.6) and 9.3m (95% CI, 7.7 - 10.9) for groups A and B respectively (P=0.25). Grade 3/4 neutropenia was worse (P<0.001) in group B. Febrile neutropenia and severe infections were more prominent (P<0.001, P=0.005 respectively) in group B. Conclusions: Although RR, PFS, OS are similar in both groups, toxicity is significantly worse in group B and therefore further investigation of PV is of no value. No significant financial relationships to disclose.

scholarly journals Plasma MicroRNA Levels Following Resection of Metastatic Melanoma

2017 ◽  
Vol 11 ◽  
pp. 117793221769483 ◽  
Author(s):  
Nicholas Latchana ◽  
Zachary B Abrams ◽  
J Harrison Howard ◽  
Kelly Regan ◽  
Naduparambil Jacob ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Inflammatory Responses ◽  
Expression Profiles ◽  
Stage Iv ◽  
Principal Component ◽  
Stage Iii ◽  
Disease Stage ◽  
Stage Iv Disease ◽  
Group A ◽  
Group B

Melanoma remains the leading cause of skin cancer–related deaths. Surgical resection and adjuvant therapies can result in disease-free intervals for stage III and stage IV disease; however, recurrence is common. Understanding microRNA (miR) dynamics following surgical resection of melanomas is critical to accurately interpret miR changes suggestive of melanoma recurrence. Plasma of 6 patients with stage III (n = 2) and stage IV (n = 4) melanoma was evaluated using the NanoString platform to determine pre- and postsurgical miR expression profiles, enabling analysis of more than 800 miRs simultaneously in 12 samples. Principal component analysis detected underlying patterns of miR expression between pre- vs postsurgical patients. Group A contained 3 of 4 patients with stage IV disease (pre- and postsurgical samples) and 2 patients with stage III disease (postsurgical samples only). The corresponding preoperative samples to both individuals with stage III disease were contained in group B along with 1 individual with stage IV disease (pre- and postsurgical samples). Group A was distinguished from group B by statistically significant analysis of variance changes in miR expression ( P < .0001). This analysis revealed that group A vs group B had downregulation of let-7b-5p, miR-520f, miR-720, miR-4454, miR-21-5p, miR-22-3p, miR-151a-3p, miR-378e, and miR-1283 and upregulation of miR-126-3p, miR-223-3p, miR-451a, let-7a-5p, let-7g-5p, miR-15b-5p, miR-16-5p, miR-20a-5p, miR-20b-5p, miR-23a-3p, miR-26a-5p, miR-106a-5p, miR-17-5p, miR-130a-3p, miR-142-3p, miR-150-5p, miR-191-5p, miR-199a-3p, miR-199b-3p, and miR-1976. Changes in miR expression were not readily evident in individuals with distant metastatic disease (stage IV) as these individuals may have prolonged inflammatory responses. Thus, inflammatory-driven miRs coinciding with tumor-derived miRs can blunt anticipated changes in expression profiles following surgical resection.

Efficacy and Safety of Oral Ivermectin and Topical Permethrin in the Treatment of Scabies

2020 ◽  
Vol 33 (1) ◽  
pp. 41-47
Author(s):  
Mohsena Akhter ◽  
Ishrat Bhuiyan ◽  
Zulfiqer Hossain Khan ◽  
Mahfuza Akhter ◽  
Gulam Kazem Ali Ahmad ◽  
...  
Keyword(s):  
Skin Diseases ◽  
Close Contact ◽  
Randomized Study ◽  
Sarcoptes Scabiei ◽  
Efficacy And Safety ◽  
Common Skin ◽  
Group A ◽  
The Mean ◽  
The Difference ◽  
Group B

Background: Scabies is one of the most common skin diseases in our country. It is caused by the mite Sarcoptes scabiei var hominis, which is an ecto-parasite infesting the epidermis. Scabies is highly contagious. Prevalence is high in congested or densely populated areas. Individuals with close contact with an affected person should be treated with scabicidal which is available in both oral and topical formulations. The only oral but highly effective scabicidal known to date is Ivermectin. Amongst topical preparations, Permethrin 5 % cream is the treatment of choice. Objective: To evaluate the efficacy & safety of oral Ivermectin compared to topical Permethrin in the treatment of scabies. Methodology: This prospective, non-randomized study was conducted at the out-patient department of Dermatology and Venereology of Shaheed Suhrawardy Medical College & Hospital over a period of 6 months, from August 2016 to January 2017. The study population consisted of one hundred patients having scabies, enrolled according to inclusion criteria. They were divided into two groups. group A was subjected to oral Ivermectin and the group B to Permethrin 5% cream. Patients were followed up on day 7 and 14 for assessment of efficacy and safety. Result: The mean scoring with SD in group A (Ivermectin) and group B (Permethrin) were 8.26 ± 2.22 and 7.59 ± 2.01 respectively at the time of observation. The difference between the mean score of the two group is not significant (p=0.117) the mean scoring with SD in group A and group B were 4.54 ± 2.05 and 1.64 ± 1.84 respectively at 7thdays. The difference between the mean score of the two group is significant (p<0.001). The mean scoring with SD in group A and group B were 2.68± 2.35 and .36± 1.10 respectively at 14th day difference between the mean score of the group is significant (p<0.001). Conclusion: Topical application of permethrin 5% cream is more effective and safer than oral Ivermectin in the treatment of scabies. TAJ 2020; 33(1): 41-47

Survival of classic swine fever virus in hams made from the meat of pigs vaccinated with the PAV-250 strain and unvaccinated pigs

2019 ◽  
Vol 10 (3) ◽  
pp. 536-551
Author(s):  
Heidi Amezcua Hempel ◽  
María Salud Rubio Lozano ◽  
Eliseo Manuel Hernández Baumgarten ◽  
Pablo Correa Girón † ◽  
Oscar Torres Ángeles ◽  
...  
Keyword(s):  
Reference Strain ◽  
Clinical Signs ◽  
Classical Swine Fever ◽  
Fever Virus ◽  
Direct Immunofluorescence ◽  
Biometric Analysis ◽  
Treatment Groups ◽  
Group A ◽  
Group B ◽  
Group D

The study was to determine the presence of Classical Swine Fever virus (CSFv), in the meat of vaccinated pigs with the PAV-250 strain and then challenged using the same strain. Five treatment groups were established (each with four pigs). Group A: Pigs thatwere fed with processed hams from negative animals; Group B: Pigs that were fed with processed hams from commercial pigs inoculated with the ALD (reference strain) (titre of 104.0/ml); Group C: Pigs fed with processed hams from pigs infected with the virulent ALD strain (titre of 102.5/ml); Group D: Pigs fed with processed hams from pigs vaccinated with the PAV-250 strain and challenged with the ALD strain (titre of 101.1/ml); and Group E: Pigs fed with processed hams from pigs vaccinated with two doses of the PAV-250 strain and challenged with the ALD strain (negative). Blood samples were taken at d 1, 5, 10, 15 and 20 for biometric analysis. Groups B, C and D manifested clinical signs of CSFv: 40 °C temperature, anorexia, paralysis, vomiting, diarrhea, tremor, hirsute hair and cyanosis. Pigs were slaughtered and necropsies performed to identify lesions in tissues. Results of direct immunofluorescence testing of tissues were positive and the virus was recovered. Under these study conditions, it was found that CSFv resisted the cooking method at 68 °C for 40 min in hams from unvaccinated pigs, and that the virus was able to transmit the disease to healthy unvaccinated pigs, whereas the hams from the vaccinated animals did not transmit the virus.

Anterior approach levator plication for congenital ptosis, absorpable versus non absorpable sutures

2021 ◽  
pp. 112067212110053
Author(s):  
Moustafa Salamah ◽  
Ashraf Mahrous Eid ◽  
Hani Albialy ◽  
Sherif Sharaf EL Deen
Keyword(s):  
Randomized Study ◽  
Early Postoperative Period ◽  
Polyglactin 910 ◽  
Exclusion Criteria ◽  
Congenital Ptosis ◽  
History Of ◽  
Group A ◽  
Group B ◽  
Over Time

Purpose: To compare the efficacy of two different suture types in levator plication for correction of congenital ptosis. Subjects and methods: Prospective comparative interventional randomized study involving 42 eyes of 42 patients aged more than 6 years with congenital ptosis and good levator action. The exclusion criteria were as follows: bilateral ptosis, history of previous surgery, fair or poor levator action, and associated other ocular diseases. Patients were randomized into group A, in which double-armed 5/0 polyester Ethibond were used, and group B, in which double-armed 5/0 Coated Vicryl® (polyglactin 910) suture material we used. Outcomes including eyelid height and stability of eyelid height over time were compared with follow-up data. The MRD was 4.05 ± 0.36 mm and 3.95 ± 0.34 after 1 week for both groups A and B, respectively. At the end of study follow up period (24 weeks), the MRD was 3.60 ± 0.42 mm in group A, and 2.52 ± 0.85 mm in group B. Conclusion: No difference in eyelid height between two groups in early postoperative period, but the postoperative eyelid height was more stable over time in the 5/0 polyester Ethibond group (group A) than in the 5/0 Coated Vicryl® (polyglactin 910) group (group B).

scholarly journals The Role of Pathological Method and Clearance Definition for the Evaluation of Margin Status after Pancreatoduodenectomy for Periampullary Cancer. Results of a Multicenter Prospective Randomized Trial

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2097
Author(s):  
Gennaro Nappo ◽  
Domenico Borzomati ◽  
Alessandro Zerbi ◽  
Paola Spaggiari ◽  
Ugo Boggi ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Randomized Study ◽  
Periampullary Cancer ◽  
Significant Prognostic Factor ◽  
Prognostic Role ◽  
R1 Resection ◽  
Group A ◽  
Group B

Background: There is extreme heterogeneity in the available literature on the determination of R1 resection rate after pancreatoduodenectomy (PD); consequently, its prognostic role is still debated. The aims of this multicenter randomized study were to evaluate the effect of sampling and clearance definition in determining R1 rate after PD for periampullary cancer and to assess the prognostic role of R1 resection. Methods: PD specimens were randomized to Leeds Pathology Protocol (LEEPP) (group A) or the conventional method adopted before the study (group B). R1 rate was determined by adopting 0- and 1-mm clearance; the association between R1, local recurrence (LR) and overall survival (OS) was also evaluated. Results. One-hundred-sixty-eight PD specimens were included. With 0 mm clearance, R1 rate was 26.2% and 20.2% for groups A and B, respectively; with 1 mm, R1 rate was 60.7% and 57.1%, respectively (p > 0.05). Only in group A was R1 found to be a significant prognostic factor: at 0 mm, median OS was 36 and 20 months for R0 and R1, respectively, while at 1 mm, median OS was not reached and 30 months. At multivariate analysis, R1 resection was found to be a significant prognostic factor independent of clearance definition only in the case of the adoption of LEEPP. Conclusions. The 1 mm clearance is the most effective factor in determining the R1 rate after PD. However, the pathological method is crucial to accurately evaluate its prognostic role: only R1 resections obtained with the adoption of LEEPP seem to significantly affect prognosis.

scholarly journals Surgery without knife: an ideal treatment for lactational breast abscess

2017 ◽  
Vol 5 (1) ◽  
pp. 261
Author(s):  
Amandeep Saharan ◽  
Satish Dalal ◽  
Mahavir Singh ◽  
Chisel Bhatia ◽  
Tulit Chhabra
Keyword(s):  
Randomized Study ◽  
Needle Aspiration ◽  
Breast Abscess ◽  
Ultrasound Guided ◽  
Incision And Drainage ◽  
Skin Changes ◽  
Lactating Mothers ◽  
Group A ◽  
Group B ◽  
Early Healing

Background: Incidence of breast abscess is 0.4 to 11% of all lactating mothers. Traditionally the treatment of breast abscess has been incision and drainage. Recently aspiration under ultrasound guidance is emerging as another treatment option and rapidly replace incision and drainageMethods: Authors carried out a prospective, randomized study involving 50 lactating women with breast abscess. In group A - 25 patients were managed by ultrasound guided needle aspiration and in group B - 25 patients were managed by incision and drainage.Results: In patients of group A, most breast abscesses resolved with one or two aspirations only, with early healing and lesser number of hospital visits as compared to patients in group B. There was no surgical scar and early resumption of breastfeeding was seen in group A.Conclusions: Ultrasound guided percutaneous aspiration is an effective modality of treatment of lactational breast abscess and it should be the first line of treatment, especially for smaller and unilocular breast abscesses while incision and drainage should be reserved for larger and multilocular abscesses with imminent skin changes.

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