scholarly journals The study of short-term efficacy of intralesional injection of combination of triamcinalone, hyaluronidase and mitomycin in Peyronies disease

2018 ◽  
Vol 6 (1) ◽  
pp. 183
Author(s):  
Raghupathi S. ◽  
Raghavendra .
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Treatment Options ◽  
Intralesional Injection ◽  
Penile Curvature ◽  
Plaque Size ◽  
Overall Response ◽  
Drug Concentrations ◽  
Pharmacologically Active

Background: Peyronies disease (PD) is physiologically and psychologically devastating disorder that is manifest by a fibrous inelastic scar of tunica albugenia resulting in palpable penile scar and deformity. Different modalities of nonsurgical treatment options exist without promising results in the long-term improvements of symptoms. The injection of pharmacologically active agents directly in to the penile plaque results in localized delivery and higher drug concentrations inside the plaque. With this rationale the study is planned to analyze the effectiveness of intralesional injection of triamcinalone, hyaluronidase, and mitomycin in the treatment of PD.Methods: Patients with symptomatic PD presenting at PGIMER from 1st July 2013 to 30th September 2014 were included in the study after obtaining the informed consent. A freshly prepared solution of a mixture of Triamcinalone, Hyaluronidase and Mitomycin was injected at the periphery as well as in the plaque. The patients were followed up for every four weeks for three months for the improvement of symptoms.Results: A total of 21 patients of symptomatic Peyronies disease with mean age of 44.4 and mean duration of 5.6 months were treated and followed up at PGIMER during July 2012 to September 30th, 2014. After completion of 3 months of treatment, 15/21 patients showed improvement in penile curvature. The overall response rate was 71.4% (p=0.001). 14/21 patients showed improvement in plaque size. The overall response rate was 66.66 (p=0.036). The IIEF-15 and PROSB score improved significantly both at 1st and 3rd month of follow up from the baseline score.Conclusions: This pilot study showed that the intralesional injection therapy is safe, well tolerated and effective in reducing the plaque size, penile curvature, and erectile dysfunction and patient’s bothersome score.

Long-term disease control with capecitabine in advanced breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12566-e12566
Author(s):  
Giovanna Masci ◽  
Emanuela Ferraro ◽  
Rosalba Torrisi ◽  
Laura Giordano ◽  
Monica Zuradelli ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Disease Control ◽  
Overall Response Rate ◽  
Response Rate ◽  
Active Agent ◽  
Advanced Breast ◽  
Overall Response ◽  
Metastatic Setting

e12566 Background: Capecitabine is an active agent in the treatment of advanced breast cancer (ABC). It is commonly administered at the approved dosage of 1250 mg/m2 twice daily for 2 weeks followed by 1 week rest period. Methods: The study population included 162 pts retrospectively analyzed with ABC treated with capecitabine between 2006 and 2015 at our Institute. Capecitabine was given 14 day on,7 day off cycle at a daily dose of 1900 mg/m2, a modified schedule used to minimize side effects. The objective were overall response rate (ORR), median duration of treatment (MDT) progression-free survival (PFS), overall survival (OS). Results: The median age was 64 years (range 33-89). Pts with hormone receptor positive ABC were 133 (82%), 6 (4%) had HER-2 positive disease and 29 (18%) a triple negative profile. One hundred and thirty eight (85%) had already received chemotherapy in adjuvant and/or metastatic setting; anthracycline and taxanes were given in 64 pts (40%), anthracycline in 60 pts (37%) and taxane in 4 pts (2%), 9 pts (6%) received other regimens of chemotherapy. Twenty-five pts (15%) were chemo-naive. One hundred and thirty-three pts (82%) received endocrine therapy. Sixty-four pts (38%) had predominantly non-visceral metastases, 26 pts (16%) exclusive visceral involvement, 72 (44%) exhibited both characteristics. ORR was 58% (CR = 2%, PR = 16% SD = 40%) and MDT was 6.9 months. The median PFS and OS were 6.9 months and 21 months, respectively. We defined as “long responders” 19 pts (12%) with disease control interval > 24 months and, among them, as “very long responders”, 9 pts (6%) who exceeded 36 months. Efficacy was unrelated to biological profiles, sites of metastasis or previous therapies. No grade 3 and 4 adverse events occurred. Conclusions: Our results show that in pts with ABC a lower dose of capecitabine has a good toxicity profile and similar overall response rate and survival data in comparison to the approved dose. In addition, we identified a subset of long and very long responders but further studies are warranted to evaluate clinical/biological predictors of a long-term response.

AOP2014, a Novel Peg-Proline-Interferon Alpha-2b with Improved Pharmacokinetic Properties, Is Safe and Well Tolerated and Shows Promising Efficacy in Patients with Polycythemia Vera (PV)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 175-175 ◽  
Author(s):  
Heinz Gisslinger ◽  
Robert Kralovics ◽  
Bettina Gisslinger ◽  
Daniel Lechner ◽  
Veronika Buxhofer-Ausch ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase I ◽  
Research Funding ◽  
Overall Response Rate ◽  
Response Rate ◽  
Phase Iii ◽  
Molecular Response ◽  
Overall Response ◽  
Long Term Treatment

Abstract Abstract 175 AOP2014 is a next generation long-acting pegylated IFNa-2b, consisting predominantly of only one isoform, as opposed to other commercially available pegylated interferons. AOP2014 has a distinct pharmacokinetic and pharmacodynamic profile which may potentially allow reduced dosing frequencies compared to other pegylated IFNs. This is being expected to result in improved tolerability, better compliance, and, finally, favorable long-term treatment outcomes. AOP2014 is a designated Orphan Drug in EU for treatment of patients with PV. The maximum tolerated dose (MTD), long term safety and efficacy of AOP2014, administered subcutaneously every 14 days, are the main objectives of the study. Patients with confirmed PV diagnosis, age equal or older 18 years, both naïve and cytoreduction pre-treated are eligible. After establishing the MTD, an extended cohort of 25 additional patients was planned to be recruited. European LeukemiaNet criteria were used for response assessment. 34 patients, treated by March 31, 2012 were included into this analysis: 25 in Phase I (dose-finding) and 9 in the Phase II (cohort extension). Median time from diagnosis was 24 months (range 0–180). 12 patients (35%) were HU pre-treated (mean past duration of HU pre-treatment 39 months, mean daily HU dose 950 mg). Median number of phlebotomies in the past 3 months prior to inclusion was 1 (range 0–8), a total of 21 patients (62%) were regularly phlebotomized at least once in three months prior to study entry. 11 patients (32%) had a history of thrombotic complications. Median Hct at baseline was 42% (range 36–51). Median WBC and platelet counts were 10.6*109/l (range 3.9–20.4) and 452*109/l (range 141–1019), respectively. 17 patients (50%) had splenomegaly at baseline. The median reported treatment duration was 41 weeks (range: 1 day – 80 weeks), 11 patients completed 1 year on treatment. Doses from 50 to 540 ug every two weeks were tested, 540 ug has been concluded as MTD as the highest tested dose, since no DLTs occurred in the study. The mean administered dose (both Phase I and II patients) was 287 ug. After 28 weeks of treatment (21 evaluable patients), 71% of patients had hematological response (7 CR, 33%; 8 PR, 38%), at week 36 (19 evaluable patients) 8 patients (42%) achieved a CR and 8 patients (42%) a PR, overall response rate (ORR, CR+PR) was 84%. At week 52 (1 year; 11 evaluable patients), 5 patients (46%) had CR and 5 (46%) PR, ORR was 91%; 8 (73%) patients presented with completely normalized blood values, all evaluable patients were phlebotomy free at this timepoint. 4 patients (of 12 evaluable for this measurement, 33%) had still enlarged spleen at week 52. At week 76, 2 evaluable patients were complete responders. At week 52, 1 patient (of 9 evaluable, 11%) developed partial molecular response, at week 68 3 patients (of 7 evaluable, 43%) had partial molecular response. One patient with allelic burden of 22% at baseline developed complete molecular response at week 36 (still ongoing). Mainly grade 1 and 2 adverse events were reported. A total of 358 adverse events occurred. 27 patients (79%) suffered from drug-related adverse events. 9 patients (26%) developed serious adverse events; 4 SAEs were considered to be treatment related. 5 patients (15%) discontinued their study participation prematurely, 3 of them due to adverse events (deterioration of underlying disease and two cases of depression). Acceptable tolerability and durable clinical benefits have been demonstrated in PV patients measured as overall response rate of above 90% with CRs of 46% at one year after treatment start. Phlebotomy independence and normalization of hematological parameters could be seen in most of the patients. The study continues to recruit and collect long term follow up information. Presented data support further development of AOP2014 in PV, a Phase III study is planned to start early 2013. Disclosures: Gisslinger: AOP Orphan Pharmaceuticals AG: Research Funding; Novartis: Speakers Bureau; Celgene Austria: Research Funding, Speakers Bureau. Kralovics:AOP Orphan Pharmaceuticals AG: Research Funding. Gisslinger:AOP Orphan Pharmaceuticals AG: Research Funding. Lechner:AOP Orphan Pharmaceuticals AG: Research Funding. Buxhofer-Ausch:AOP Orphan Pharmaceuticals AG: Research Funding. Strecker:AOP Orphan Pharmaceuticals AG: Research Funding. Gastl:AOP Orphan Pharmaceuticals AG: Research Funding. Willenbacher:AOP Orphan Pharmaceuticals AG: Research Funding. Greil:AOP Orphan Pharmaceuticals AG: Research Funding. Egle:AOP Orphan Pharmaceuticals AG: Research Funding. Melchardt:AOP Orphan Pharmaceuticals AG: Research Funding. Burgstaller:AOP Orphan Pharmaceuticals AG: Research Funding. Schloegl:AOP Orphan Pharmaceuticals AG: Research Funding. Tarmann:AOP Orphan Pharmaceuticals AG: Employment. Zoerer:AOP Orphan Pharmaceuticals AG: Employment. Klade:AOP Orphan Pharmaceuticals AG: Employment. Zahriychuk:AOP Orphan Pharmaceuticals AG: Employment. Thaler:AOP Orphan Pharmaceuticals AG: Research Funding.

scholarly journals Real-world efficacy of docetaxel plus nintedanib after chemo-immunotherapy failure in advanced pulmonary adenocarcinoma

2021 ◽  
Author(s):  
Martin Metzenmacher ◽  
Filippo Rizzo ◽  
Kato Kambartel ◽  
Jens Panse ◽  
Diana Schaufler ◽  
...  
Keyword(s):  
Disease Control ◽  
Real World ◽  
Overall Response Rate ◽  
Response Rate ◽  
Treatment Options ◽  
Pulmonary Adenocarcinoma ◽  
Disease Control Rate ◽  
Overall Response ◽  
Clinical Benefits ◽  
Third Line

Aim: This real-world analysis evaluated docetaxel plus nintedanib in patients with advanced pulmonary adenocarcinoma after chemotherapy and immune checkpoint inhibitor failure, for whom treatment options are limited. Methods: Data were sourced retrospectively from seven German centers. Results: Of 93 patients, overall response rate was 41.4% (disease control rate: 75.9%). Of 57 patients given third-line docetaxel plus nintedanib, overall response rate was 50.0% (disease control rate: 82.7%). Median overall survival following third-line docetaxel plus nintedanib was 8.4 months. Adverse events were consistent with the known safety profile of docetaxel plus nintedanib. Conclusion: To date, this was the largest retrospective, real-world analysis of docetaxel plus nintedanib after chemotherapy–immunotherapy failure, indicating that docetaxel plus nintedanib offers meaningful clinical benefits in this setting.

Gleevec Therapy in Advanced Phases of the Cml - Polish Study Report.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4701-4701
Author(s):  
Bernadeta B. Ceglarek ◽  
Lech J. Konopka ◽  
Anna Sikorska ◽  
Kinga Kos ◽  
Jerzy Holowiecki ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Kinase Inhibitor ◽  
Blast Crisis ◽  
Treatment Options ◽  
Single Agent ◽  
Chronic Phase ◽  
Significant Activity ◽  
Duration Of Treatment ◽  
Overall Response

Abstract Accelerated phase marks the onset of advanced rapidly progressive chronic myelogenous leukaemia (CML) and generally leads finally to a fatal blast crisis (BC) within 6 months. Gleevec (imatinib mesylate) as a potent tyrosine kinase inhibitor has demonstrated significant activity in chronic phase (CP) of CML. Because of the observed activity and favorable tolerability of Gleevec and because of the limited treatment options available to these patients we have introduced Gleevec in CML patients meeting rigorous criteria for acceleration and blast crisis phase of CML. PATIENTS: MALE - 31 and FEMALE - 20 were eligible for inclusion in this study if they were at least 18 years old and had a diagnosis of Ph+ CML (AP; BC) confirmed by cytology, histology, cytogenetic and molecular analyses. Characteristics CML patients (AP-accelerated phase; BC-blast crisis phase) is showed in table 1. Table 1- Demographics, Disease History and Characteristics of CML Patients. 1 Duration time of CML-yr 3.8 (1–4.5) 3.7 (0.7–5.1) Prior therapy -n(%) 100% 100% combined Chemotherapy 10 (33) 18 (86) BMT 2 (6.6) 0 Sokal’s score >0.8 16 (53) 15 (71) PLT (x 109/L) 100.0–300.0 11 (37) 8 (38) >300.0 15 (50) 4 (19) Blasts in peripheral blood (%) median 9 34 range 4–20 31–80 Blasts in bone marrow (%) range 10–25 32–78 HGB (g%) median 6.24 6.12 range 5.0–9.4 4.4–10.0 Gleevec dosage AP BC 300mg: n (%) 1 (3.3) 1 (4.8%) 400 mg: n (%) 4 (13.3) 1 (4.8) 600–800 mg: n (%) 25 (83.4) 19 (90.4) Duration of treatment (months) AP BC median 31.64 40.0 range 1–98 0.5–91 Patients received Gleevec 300–800 mg orally daily (table 2). Clinical evaluation of Gleevec therapy was determined by the rate of sustained haematological response (lasting >= 4 weeks) The results of Gleevec therapy are showed in table 2. Table 2 - Haematologic Response in Patients with AP & BC Phase after Gleevec Treatment Response AP BC 2 CHR 25 (83.3%) 4 (19.0%) Cytogenetic response Major : 5 (16.7%) 1 (4.8%) CCR 2 (6.7%) 0 PCR 3 (10.0%) 1 (4.8%) Minimal 11 (36.7%) 1.4.8%) No response 9 (30%) 18 (85.6%) BMT performed 5 (16.7%) 2 (9.6%) after Gleevec therapy (months) 6–12 7–13 The most often observed side effects were irst few months ( neutropenia, thrombocytopenia, weakness, bone and muscles pain, headache, nausea, vomiting, diarrhoea, legs’ oedema, deaths (6.3% – 27.3%). Conclusions: Imatinib as a single agent is well tolerated and has substantial activity in the accelerated phase of CML. The overall response rate in these cases was 83%. Imatinib as a single agent is well tolerated and has substantial activity in the accelerated phase of CML. The overall response rate in these cases was 83%. Imatinib as a single agent is well tolerated and has substantial activity in the accelerated phase of CML. The overall response rate in these cases was 83%. 5 pts. out of these 30 patients are still in the chronic phase after 10 to 32 months of follow-up. In 4 ( 19%) out of 21 patients with BC the improvement after Gleevec therapy was short and transient mainly due to advanced stage of disease.

scholarly journals PD-1 Blockade in Anaplastic Thyroid Carcinoma

2020 ◽  
Vol 38 (23) ◽  
pp. 2620-2627 ◽  
Author(s):  
Jaume Capdevila ◽  
Lori J. Wirth ◽  
Thomas Ernst ◽  
Santiago Ponce Aix ◽  
Chia-Chi Lin ◽  
...  
Keyword(s):  
Adverse Events ◽  
Thyroid Carcinoma ◽  
Overall Response Rate ◽  
Response Rate ◽  
Treatment Options ◽  
Locally Advanced ◽  
Complete Response ◽  
Anaplastic Thyroid Carcinoma ◽  
Overall Response ◽  
Humanized Monoclonal Antibody

PURPOSE Anaplastic thyroid carcinoma is an aggressive malignancy that is almost always fatal and lacks effective systemic treatment options for patients with BRAF-wild type disease. As part of a phase I/II study in patients with advanced/metastatic solid tumors, patients with anaplastic thyroid carcinoma were treated with spartalizumab, a humanized monoclonal antibody against the programmed death-1 (PD-1) receptor. METHODS We enrolled patients with locally advanced and/or metastatic anaplastic thyroid carcinoma in a phase II cohort of the study. Patients received 400 mg spartalizumab intravenously, once every 4 weeks. The overall response rate was determined according to RECIST v1.1. RESULTS Forty-two patients were enrolled. Adverse events were consistent with those previously observed with PD-1 blockade. Most common treatment-related adverse events were diarrhea (12%), pruritus (12%), fatigue (7%), and pyrexia (7%). The overall response rate was 19%, including three patients with a complete response and five with a partial response. Most patients had baseline tumor biopsies positive for PD-L1 expression (n = 28/40 evaluable), and response rates were higher in PD-L1–positive (8/28; 29%) versus PD-L1–negative (0/12; 0%) patients. The highest rate of response was observed in the subset of patients with PD-L1 ≥ 50% (6/17; 35%). Responses were seen in both BRAF-nonmutant and BRAF-mutant patients and were durable, with a 1-year survival of 52.1% in the PD-L1–positive population. CONCLUSION To our knowledge, this is the first clinical trial to show responsiveness of anaplastic thyroid carcinoma to PD-1 blockade.

Comparative Efficacy of Hidrocystoma Treatments: A Systematic Review

2020 ◽  
Vol 24 (5) ◽  
pp. 474-480
Author(s):  
Thomas Trischman ◽  
Jeffrey F. Scott
Keyword(s):  
Systematic Review ◽  
Recurrence Rate ◽  
Surgical Procedures ◽  
Overall Response Rate ◽  
Response Rate ◽  
Treatment Options ◽  
Treatment Modalities ◽  
Comparative Efficacy ◽  
Overall Response ◽  
Medical Therapies

Introduction Although various treatment options for hidrocystomas have been described, the comparative efficacy of these treatments is poorly understood. Methods We conducted a systematic review of all articles describing the treatment of hidrocystomas. Treatment modalities were categorized as destructive surgical procedures, skin-directed therapies, systemic medical therapies, general measures, or combined. Patient and tumor characteristics, as well as response rate, recurrence rate, and adverse effects, were extracted from each article. Results A total of 94 articles involving 192 patients and 255 unique treatment events were included in the final analysis. Destructive surgical procedures had an overall response rate and recurrence rate of 92.9% and 10.8%, respectively. Skin-directed therapies had an overall response rate of 72.6%. The overall response rate to systemic medical therapies was 71.4%. Solitary hidrocystomas were primarily treated with destructive surgical procedures, including excision, which was associated with a 4.7% recurrence rate. Multiple hidrocystomas were successfully treated with a variety of therapies, including destructive surgical procedures and skin-directed therapies requiring ongoing or repeated therapy. Conclusions Excision has the highest efficacy for solitary hidrocystomas. A number of therapies have shown efficacy for multiple hidrocystomas, including lasers, intracystic trichloroacetic acid, intracystic hypertonic glucose, topical and oral anticholinergics, and botulinum toxin. Aluminum chloride is associated with a low response rate. Larger comparative studies are needed to further evaluate the optimal treatments for solitary and multiple hidrocystomas.

scholarly journals Long Term Outcome of Pediatric Patients with Severe Aplastic Anemia Treated with Anti-Thymocyte Globulin and Cyclosporine.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1694-1694
Author(s):  
Phillip Scheinberg ◽  
Colin O. Wu ◽  
Olga Nunez ◽  
Neal Young
Keyword(s):  
Young Adults ◽  
Aplastic Anemia ◽  
Cumulative Incidence ◽  
Pediatric Patients ◽  
Overall Response Rate ◽  
Response Rate ◽  
Age Group ◽  
Term Survival ◽  
Overall Response

Abstract Acquired severe aplastic anemia (SAA) is a fatal bone marrow failure disorder which commonly affects the young. An increased incidence of SAA is observed in children and young adults between the ages of 15 and 25. In those who have a histocompatible sibling donor, hematopoietic stem cell transplantation (HSCT) is often performed; for the remainder of patients immunosuppressive therapy (IST) with an anti-thymocyte globulin (ATG) based regimen is the treatment of choice. The overall response rate (children + adults) to ATG is 60–70%, with prolonged survival achieved in 70–80% of cases. Most of the reports on the efficacy of IST with ATG in children are of small cohorts. Here we report the outcome of children under the age of 18 treated with horse ATG + cyclosporine (CsA) at our institution from 1989 to 2006. Overall 77 received horse ATG as the initial IST. The overall response rate at 6 months was 74% (57/77); the cumulative incidence of relapse at 10 years was 33% and the median time to relapse was 558 days. The cumulative incidence of evolution following IST was 8.5%; all 3 cases occurred among partial responders. Cytogenetic abnormalities that were detected after IST were: monosomy 7 in two patients and deletion 13q in one patient. Overall there were 13 deaths (17%): four occurred within the 3 months following IST in patients who had a pre-treatment ANC of less than 100/uL and nine deaths occurred further than 6 months of IST. The median time to death was 570 days. The overall 10-year survival for the entire cohort was 80%; long term survival in patients who responded to IST was 89%. We conducted a separate analysis in the age group of 18–21. In total, 35 patients in this age group were treated with h-ATG-based IST from 1989 to 2006. The overall hematologic response rate was 60% (21/35) of which 7 relapsed (33%). The overall response rate among children (< 18) was about 75% which is higher than what is observed in older patients at our institution (response rate of about 60%). The response rate in young adults approximates the overall adult response rate. The long term survival in pediatrics patients who respond to IST is very favorable at about 90%. IST remains a very good alternative in pediatric patients who lack an HLA-matched sibling donor and should be offered as initial therapy prior to an alternative HSCT.

Cisplatin in the treatment of recurrent childhood primary brain tumors.

1988 ◽  
Vol 6 (1) ◽  
pp. 62-66 ◽  
Author(s):  
R W Walker ◽  
J C Allen
Keyword(s):  
Brain Tumors ◽  
Germ Cell ◽  
Germ Cell Tumor ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Tumor ◽  
Primitive Neuroectodermal Tumors ◽  
Primary Brain Tumors ◽  
Overall Response ◽  
Neuroectodermal Tumors

Thirty-three patients were treated with intravenous (IV) cisplatin (CPDD) of whom 32 were considered evaluable. There were 14 medulloblastomas, five primitive neuroectodermal tumors (PNET), nine gliomas, three ependymomas, and one germ cell tumor. The overall response rate was 13 of 32 (41%). Eleven responses (five complete [CR], five partial [PR], one mixed [MR]) were noted in the patients with medulloblastoma. The response rate within this group was 79%. Toxicity was tolerable, although it precluded further therapy in five patients.

scholarly journals Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus: A Retrospective Study

2021 ◽  
pp. 014556132110168
Author(s):  
Haidi Yang ◽  
Gui Cheng ◽  
Zhengrong Liang ◽  
Wenting Deng ◽  
Xiayin Huang ◽  
...  
Keyword(s):  
Transcranial Magnetic Stimulation ◽  
Magnetic Stimulation ◽  
Overall Response Rate ◽  
Response Rate ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Subjective Assessment ◽  
Overall Response ◽  
Duration Of Disease ◽  
Vas Scores ◽  
Assessment Result

Objective: Current studies still find insufficient evidence to support the routine use of repetitive transcranial magnetic stimulation (rTMS) in tinnitus. This study aimed to assess response of tinnitus to treatment with rTMS and identify factors influencing the overall response. Methods: Between January 2016 and May 2017, 199 tinnitus patients were identified from a retrospective review of the electronic patient record at the Sun Yat-sen Memorial Hospital. All patients received rTMS treatment. Their clinicodemographic profile and outcomes, including the tinnitus handicap inventory (THI) and visual analog scale (VAS) scores, were extracted for analysis. Results: Regarding the THI results, 62.3% of all patients responded to rTMS. The analysis of the VAS score revealed an overall response rate of 66.3%. Both percentages were close to the patient’s subjective assessment result, of 63.8%. Patients with tinnitus of less than 1-week duration had the highest response rate to rTMS in terms of either THI/VAS scores or the patient’s subjective assessment of symptoms. Tinnitus duration was recognized as a factor influencing the overall response to the treatment. Conclusions: Repetitive transcranial magnetic stimulation treatment is effective for patients with tinnitus, but its efficacy is affected by tinnitus duration. Tinnitus patients are advised to attend for rTMS as soon as possible since therapy was more effective in those with a shorter duration of disease of less than 1 week.

Combination of trastuzumab, pertuzumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) harboring HER2 mutation: Final results from the IFCT-1703 R2D2 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9015-9015
Author(s):  
Julien Mazieres ◽  
Claire Lafitte ◽  
Charles Ricordel ◽  
Laurent Greillier ◽  
Jean-Louis Pujol ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Overall Response Rate ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Loading Dose ◽  
Overall Response ◽  
Grade 3 ◽  
Exon 20

9015 Background: Human epidermal growth factor receptor 2 ( HER2) exon 20 insertions and mutations are oncogenic drivers found in 1-2% of NSCLC. However, there are no approved therapies for these patients. Many studies suggest that the use of HER2 inhibitors developed for breast cancer patients might be of interest in this setting. The aim of this trial was to prospectively evaluate the interest of a combination of two antibodies against HER2 (trastuzumab and pertuzumab) with docetaxel. Methods: IFCT-1703 R2D2 trial is a multicenter, non-randomized phase 2 study with a two-stage design, a power of 90% and an alpha risk at 5% (one-sided). HER2 mutational status was assessed locally in certified molecular genetic centers. Main other inclusion criteria were advanced NSCLC, progression after ≥ 1 platinum-based chemotherapy, asymptomatic brain metastases, left ventricular ejection fraction (LVEF) ≥ 50%, and PS 0-2. Patients were treated every 3 weeks with pertuzumab at a loading dose of 840 mg, and 420 mg thereafter; plus trastuzumab at a loading dose of 8 mg/kg and 6 mg/kg thereafter; and docetaxel at 75 mg/m². Treatment was given until toxicity or disease progression. The primary outcome was overall response rate (ORR). Other endpoints included duration of response, progression-free survival and safety. NCT number: NCT03845270. Results: From May 2019 to October 2020, 45 patients were enrolled in 17 centers and received study treatment. Median age was 64.5 years (range 31–84), 72% females, 35% smokers, 100% non-squamous histology and 15% with ECOG PS 2. 31.1% patients had brain metastases. PD-L1 was expressed ≥ 1% and ≥ 50% in 36% and 7% of the patients, respectively. No other oncogene driver was found associated with HER2 exon 20 mutation. With a median follow-up of 12 months, 44 (98%) patients were evaluable for the primary endpoint. Overall response rate was 29% (n = 13), stable disease 56% (n = 26). Median PFS was 6.8 months (95% CI[4.0-8.5]). Median duration of treatment in patients with confirmed response (n = 13) was 10 months (95% CI[2.7-14.9]). At the time of data cut-off, 15 patients (33%) were still under treatment. Grade 3/4 treatment-related adverse events (AEs) were observed in 64% of patients. No patient experienced treatment discontinuation because of toxicity. One sudden death was possibly related to treatment. Most frequent grade ≥ 3 AEs were neutropenia (33%), diarrhea (13%) and anaemia (9%). Grade 1/2 dyspnea was observed in 3 (6.7%) patients. No ILD were reported. Variation LVEF was -1.72% on average (min: -18 %; max: 10 %). Conclusions: The triplet trastuzumab, pertuzumab and docetaxel is feasible and active in HER2 pretreated advanced NSCLC. These results confirm the activity of HER2 antibodies-based strategy which should be considered in these patients. Clinical trial information: NCT03845270.

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