scholarly journals Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

2020 ◽  
Author(s):  
Jian Sun ◽  
Wenjie Wang ◽  
Jing Ding ◽  
Yusheng Cheng ◽  
Yunfeng Zhou ◽  
...  

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT.Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9-12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 18-35 yr) and group B (aged 36-81 yr). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-month duration.Conclusions Younger females with FGTB had a greater risk of systemic infection of tuberculosis compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for reducing side effects and poor compliance in the duration of treatment.

2020 ◽  
Author(s):  
Jian Sun ◽  
Wenjie Wang ◽  
Jing Ding ◽  
Yusheng Cheng ◽  
Yunfeng Zhou ◽  
...  

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT.Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9-12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 18-35 yr) and group B (aged 36-81 yr). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-month duration.Conclusions Younger females with FGTB had a greater risk of systemic infection of tuberculosis compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for reducing side effects and poor compliance in the duration of treatment.


2020 ◽  
Author(s):  
Jianghua Yang ◽  
Jian Sun ◽  
Wenjie Wang ◽  
Jing Ding ◽  
Yusheng Cheng ◽  
...  

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT. Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9–12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 15–35 years) and group B (aged ≥ 36 years). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-mo duration. Conclusions Younger females with FGTB had a greater risk of systemic infection of TB compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for improving the side effects and poor compliance in the duration of treatment.


2001 ◽  
Vol 19 (8) ◽  
pp. 2232-2239 ◽  
Author(s):  
George Fountzilas ◽  
Christos Papadimitriou ◽  
Urania Dafni ◽  
Dimitrios Bafaloukos ◽  
Dimosthenis Skarlos ◽  
...  

PURPOSE: To compare the efficacy of two different schedules of epirubicin and paclitaxel, as first-line chemotherapy, in patients with advanced breast cancer (ABC). PATIENTS AND METHODS: From October 1997 until May 1999, 183 eligible patients with ABC entered the study. Chemotherapy in group A (93 patients) consisted of four cycles of epirubicin at a dose of 110 mg/m2 followed by four cycles of paclitaxel at a dose of 225 mg/m2 in a 3-hour infusion. All cycles were repeated every 2 weeks with granulocyte colony-stimulating factor support. The therapeutic regimen in group B (90 patients) consisted of epirubicin (80 mg/m2) immediately followed by paclitaxel (175 mg/m2 in a 3-hour infusion) every 3 weeks for six cycles. RESULTS: In total, 79 patients (85%) in group A and 72 patients (80%) in group B completed treatment. The median relative dose-intensity of epirubicin was 0.96 in both groups, and that of paclitaxel was 0.96 and 0.97 in groups A and B, respectively. The complete response rate was higher in group A (21.5% v 9% P = .02). Nevertheless, there was no significant difference in the overall response rate between the two groups (55% v 42%, P = .10). Severe neutropenia was more frequently observed with concurrent treatment. After a median follow-up of 16.5 months, median time to progression was 10 months in group A and 8.5 months in group B (P = .27), and median survival was 21.5 and 20 months, respectively (P = .17). CONCLUSION: The present study failed to demonstrate a significant difference in overall response rate between dose-dense sequential administration of epirubicin and paclitaxel compared with the combination of the two drugs given on the same day, even though the sequential treatment resulted in a significantly higher complete response rate.


2010 ◽  
Vol 28 (31) ◽  
pp. 4740-4746 ◽  
Author(s):  
Sonali M. Smith ◽  
Koen van Besien ◽  
Theodore Karrison ◽  
Janet Dancey ◽  
Peter McLaughlin ◽  
...  

PurposeDespite high initial remission rates, most lymphomas relapse and require further therapy. The mammalian target of rapamycin (mTOR) pathway is a validated target in mantle cell lymphoma, but has not been extensively evaluated in other lymphomas.Patients and MethodsWe performed a phase II trial of single-agent temsirolimus 25-mg weekly in patients with relapsed aggressive and indolent lymphomas. The primary objective was overall and complete response rate. Patients were stratified by histology: group A (diffuse large B-cell lymphoma, transformed follicular lymphoma), group B (follicular lymphoma), and group C (chronic lymphocytic leukemia/small lymphocytic lymphoma, and other indolent lymphomas).ResultsEighty-nine patients were treated, with outcome strongly dependent on histology. Group A had an overall and complete response rate of 28.1% and 12.5%, respectively, and median progression-free survival (PFS) of 2.6 months and median overall survival (OS) of 7.2 months. Group B had overall and complete response rates of 53.8% and 25.6%, respectively, and median PFS of 12.7 months; median OS has not yet been reached. Group C had a partial response rate of 11% with no complete responders. Toxicity was mainly mild and/or reversible myelosuppression and mucositis; however, four patients developed pneumonitis.ConclusionsSingle-agent temsirolimus has significant activity in both diffuse large B-cell lymphoma and follicular lymphoma, although the durability of responses and PFS are longer for patients with follicular lymphoma. This is the first report of substantial activity of temsirolimus in lymphomas other than mantle cell lymphoma, and supports further evaluation of mTOR as a target in these diseases.


2015 ◽  
Vol 08 (01) ◽  
pp. 1540004 ◽  
Author(s):  
Zhi-Xia Fan ◽  
Ling-Lin Zhang ◽  
Hong-Wei Wang ◽  
Pei-Ru Wang ◽  
Zheng Huang ◽  
...  

Purpose: To evaluate the effectiveness of topical 5-aminolevulinic acid (ALA)-mediated photodynamic therapy (PDT) for the treatment of cutaneous lichen planus (LP). Methods: A total of 17 symptomatic LP lesions in 7 Chinese patients were assessed. ALA cream (10%) was applied topically to LP lesions for 3 h. The lesions were irradiated with a 635 nm diode laser at the dose level of 100 J/cm2. The treatment was repeated at two-week intervals. Clinical assessment was conducted before each treatment. Follow-up was performed once a month for up to six months. Results: Lesions showed significant improvement after one to four courses of treatments. Complete response was achieved in 13 lesions (five patients) and partial remission in four lesions (two patients). The complete response rate was 71%. There was no significant side effects except the feeling of pain that most patients could tolerate. Follow-up of five patients who achieved complete response showed no signs of recurrence. Conclusion: Topical ALA PDT is effective in the treatment of cutaneous LP.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5636-5636
Author(s):  
Concetta Conticello ◽  
Enrica Antonia Martino ◽  
Vittorio Del Fabro ◽  
Giuseppe Sapienza ◽  
Valeria Calafiore ◽  
...  

Abstract Background: Triplet-based lenalidomide plus dexamethasone (Rd) combinations have become the new standard of care for early relapse and refractory multiple myeloma (RRMM). Carfilzomib is a novel selective proteasome inhibitor (PI) with high efficacy in RRMM. The ASPIRE phase 3 trial showed the superiority of carfilzomib-based triplet (KRd compared to Rd), leading to approval of K for RRMM. However, little is known about safety and efficacy of KRd outside a clinical trial context. Experimental design and aims: In 11 Sicilian Centers belonging to the Sicilian Myeloma Network, from November 2016, when KRd regimen was approved in Italy, to June 2018, 103 consecutive RRMM patients (previous lines 1-10) have received KRd regimen, according to ASPIRE schedule. Lenalidomide dosage was reduced in patients with a low count of platelet and/or renal failure according to manufacturer guidelines. Since previous studies have demonstrated that increased cumulative dose of first generation PI bortezomib significantly improved overall survival of patients treated with VMP regimen, we studied the effect of cumulative dose of Carfilzomib in RRMM patients receiving KRd. Results: Clinical and demographic characteristics of patients included in the study are summarized in Table 1. Median age was 65 years (range 33-86), most patients were males (54%). About half of the patients included in the survey were refractory to previous treatment (54%); Sixty-five (63%) patients received at least 5 cycles of KRd and 38 (36%) received at least 10 cycles. Overall response rate was 34% (35 patients); 18 patients (17%) achieved a complete response (CR), 6 patients minimal response (MR), 13 (12%) patients achieved PR, 16 patients achieved MR and then progressed; progression occurred in 20 patients, among them 3 did not reached any response. Delays due to adverse events were 33%, mainly due to febrile neutropenia (22%), thromboembolic events (4.5%), heart failure (3%), or thrombocytopenia (4.5%). To prevent hematological toxicities, 24% of patients received granulocyte growth factors, 15% erythropoietin. In 30 patients treatment was reduced (mainly due to lenalidomide toxicity) and in 5 patients discontinued for toxicity. Thus, median cumulative carfizomib doses at 2, 3, 4 and 6 cycles were respectively 480 mg (282 mg/m2), 735 mg (435 mg/m2), 995 mg (589 mg/m2) and 1522mg (890 mg/m2). After a median follow up of 16.2 months, PFS at 12 months was 67.3%. We found that median PFS was significantly longer in patients who received at least 480 mg (282 mg/m2) within first two months of treatment compared to those that could not receive full-dose KRd (respectively, undefined vs 11 months p=0.04). To identify patients that could obtain the most advantage by KRd treatment, 65 patients who had received at least six cycles were distinguished in two groups, based on previous treatments. In group A, 27 patients were heavily pretreated (median previous lines 4, range 2-10) and had previously received lenalidomide while 38 patients included in group B were less pretreated (median previous lines 3, range 1-5) and lenalidomide- naïve. We found that group A had lower PFS than group B although duration of PFS from the previous treatment was similar in both groups. Conclusions: In our cohort of patients rate of VGPR or better obtained with KRd combination was high with an overall response rate of 34%, with an acceptable safety profile. It is therefore reasonable that approaches to achieve a higher cumulative dose, such as continuing therapy in responding patients and/or proactive adverse events management, influence efficacy. In addition, it is likely that patients not previously exposed to several lines of treatment including lenalidomide are the best candidate for a favorable outcome with KRd regimen. Disclosures Di Raimondo: Celgene: Honoraria; Takeda: Honoraria, Research Funding.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8039-8039
Author(s):  
A. M. Sanguino ◽  
A. Y. Bedikian ◽  
S. S. Legha ◽  
M. A. Detry ◽  
N. E. Papadopoulos ◽  
...  

8039 Background: According to 2001 AJCC data, 1-yr, 2-yr, 5-yr, and 10-yr survival of melanoma patients (pts) with stage M1c were 40.6%, 23.6%, 9.5% and 6.0%, respectively. Previously, we reported the interim results of a randomized phase II trial comparing the response rates (RR) of CVDI vs. CVDI +T. Here we report long-term survival results of these pts. Methods: Chemo-naïve pts between 16 and 75 yrs of age, with histologically documented diagnosis of advanced melanoma and without symptomatic brain metastasis, were randomized to receive either CVDI (group A) or CVDI+T (group B). The dose of each drug is as follows: C 15 mg/m2 IV (d 2–5), V 1.2 mg/m2 IV (d 1–5), D 600 mg/m2 IV (d 1), I 5 MU/m2 SQ 3 times a wk and T 20 mg twice a day. The treatment was administered every 3–4 wks. After the interim analysis, the arm with a higher RR was selected for an expansion cohort (group C). The primary endpoint was the RR of CVDI regimen with or without T. The secondary endpoint was overall survival (OS) evaluation. Results: A total of 104 pts were enrolled, among which 36 and 34 were randomized to group A and B, respectively. After interim analysis of 70 pts, the CVDI regimen was selected for group C. There were no significant differences in both RR (p= 0.126) and OS (p= 0.095) between group A and B. When all 104 pt data were combined, the overall response rate (ORR) was 37.5% with a complete response rate (CRR) of 8.7% and the median survival of 10.4 months. One-yr, 2-yr, 5-yr, and 10-yr OS were 43%, 20%, 7% and 4%, respectively. Conclusions: Although the combination of CVDI with or without T is an active regimen for treatment for metastatic melanoma, long-term survival of pts receiving this regimen is similar to historical controls. [Table: see text] No significant financial relationships to disclose.


Author(s):  
André Deeke Sasse ◽  
Luciana Gontijo de Oliveira Clark ◽  
Emma Chen Sasse ◽  
Otávio Augusto Camara Clark

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2368-2368
Author(s):  
Shayi Jiang ◽  
Eric S. Sandler ◽  
Hui Jiang

Objective: Children with immune thrombocytopenia (ITP) are mostly self-limited, so they are usually observed closely and not need treatment in the clinical work. However, for children with platelet<10×109/L or platelet <20×109/L accompanied with obvious hemorrhagic tendency, intravenous immunoglobulin (IVIG) combined with glucocorticoids is commonly used on prevent severe bleeding. The purpose of this study is to investigate whether glucocorticoids are required at the same time in ITP children who need intravenous gamma globulin to rapidly increase platelet level. Method: 210 newly diagnosed ITP children with severe thrombocytopenia (platelet <20×109/L with obvious bleeding tendency) were randomly assigned to the non-glucocorticoid group and glucocorticoid group. The former was treated with IVIG alone, while the latter was treated with a combination of IVIG and glucocorticoid. Then each group was further divided into the infant group (<1 year old) and the older children group (≥1 year old). Clinical index such as complete response rate, relapse rate, duration of therapy and glucocorticoid side effects were analyzed and compared in each group. Results: ①The complete response rate showed no statistically differences (P>0.05) among the non-glucocorticoid infant group (95.65%) and glucocorticoid infant group (92.50%), but significant differences in the older children groups with or without glucocorticoid (100% vs 92.31%, χ²=4.720, P=0.03). ②Regard the relapse rate, it was statistically lower in non-glucocorticoid infant group than in non-glucocorticoid older children group (10.41% vs 53.35%, χ²=21.685, P<0.001); in the glucocorticoid older children group than in the non-glucocorticoid older children group (21.05% vs 53.45%, χ²=12.888, P <0.001). No statistical significance was proved among glucocorticoid infant group and non-glucocorticoid infant group (12.5% vs 10.41%, P>0.05). ③After treatment for 72 h, There was no significant difference in the number of children with the platelet count >50×109/L between glucocorticoid group and non-glucocorticoid group. ④There was a significant difference for the duration of therapy between the non-glucocorticoid group (4d) and glucocorticoid group (2 months)(Ζ=-7.430, P<0.001). ⑤32.5% patients of the glucocorticoid infant group suffered from infections, that was higher than in the non-glucocorticoid infant group(11.63%), and there was marked significance(χ²=7.031, P=0.008). The incidence of Cushing's syndrome in the infant glucocorticoid group (42.5%) was as the same as that in the older children glucocorticoid group (36.84%). No corticosteroid-related side effects were observed in all non-glucocorticoid groups. Conclusions: Intravenous immunoglobulin (IVIG) is accepted as an effective treatment for newly diagnosed infant ITP with platelet counts<20×109/L, combination with glucocorticoid provided no significant benefit for the complete response and preventing relapse, on the contrary, may lead to high risk for infections and increasing glucocorticoid side-effects. IVIG combined with glucocorticoid can make significant clinical efficacy improvement in the older children group. Key words: Immune thrombocytopenia; Intravenous immunoglobulin; glucocorticoid; Children; Relapse Disclosures No relevant conflicts of interest to declare.


Author(s):  
Shrikant . ◽  
R.D. Mehta ◽  
B.C. Ghiya

Background: Verruca is one of the common dermatopathologies which has multiple therapeutic options but with variable success rates, refractory cases and high recurrence rates. Nowadays, treatment with intralesional injections has gained recognition due to its effectiveness in clearing verrucae. These act by stimulating the cell-mediated immunity. Out of scores of options available for intralesional therapeutics, Vitamin D3 appears to be more promising but least evaluated. Therefore, we planned to evaluate the efficacy of intralesional Vitamin D3 in various types of cutaneous verrucae. Simultaneously the results were compared with intralesional bleomycin, also. Methods: A total of 200 patients of cutaneous verrucae with varying size and duration were included in the experimental randomized comparative study. We divided them into two groups. Group A, comprising of 100 patients, received 0.2-0.5 ml intralesional Vitamin D3 (600,000 IU, 15mg/ml) and Group B, also of hundred subjects, received intralesional Bleomycin (1 mg/ml) into the base of verrucae. A maximum of 5 verrucae were injected per session at 3 weeks interval until resolution or for a maximum of 4 sessions. Patients were followed up for 6 months after the last injection to assess the clearance status and detect any recurrence. Results: In Group A (Vitamin D3), 'Complete response', 'Partial response' and 'No response' were observed in 85.07%, 6.74% and 8.17% respectively after 4 sessions. Recurrence rate was 0.81% after 6 months. In Group B (Bleomycin), 'Complete response', 'Partial response' and 'No response' were found in 77.99%, 10.47% and 11.53% in the series. Recurrence rate was 1.71%, comparatively higher in group B. Conclusion: The efficacy of intralesional Vitamin D3 was found significantly higher as compared to intralesional Bleomycin in the treatment of cutaneous verrucae with less recurrence rates. Vitamin D3 has an additional advantage of cost-effective treatment over Bleomycin. We purpose its use, as a primary mode of treatment in various types of cutaneous verrucae. Keywords: Bleomycin, Vitamin D3, Verrucae.


Sign in / Sign up

Export Citation Format

Share Document