Efficacy and Safety of Gefitinib Plus Pemetrexed/Platinum in Advanced EGFR-Mutated Lung Adenocarcinoma Patients: A Real-World Observational Study

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice.

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Be-TeaM: An Italian real-world observational study on second-line therapy for EGFR-mutated NSCLC patients

Lung Cancer ◽

10.1016/j.lungcan.2019.12.006 ◽

2020 ◽

Vol 140 ◽

pp. 71-79 ◽

Cited By ~ 1

Author(s):

Maria Lucia Reale ◽

Rita Chiari ◽

Marcello Tiseo ◽

Fabiana Vitiello ◽

Fausto Barbieri ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Second Line ◽

Second Line Therapy ◽

Line Therapy ◽

Nsclc Patients ◽

Egfr Mutated

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Real World Data on the Efficacy and Safety of Ixazomib Based Therapy in Multiple Myeloma: An Observational Study from China

Clinical Lymphoma Myeloma & Leukemia ◽

10.1016/j.clml.2019.09.438 ◽

2019 ◽

Vol 19 (10) ◽

pp. e265

Author(s):

Jing Li ◽

Jingli Zhuang ◽

Zheng Wei ◽

Liji Ji ◽

Zhixiang Cheng ◽

...

Keyword(s):

Multiple Myeloma ◽

Observational Study ◽

Real World ◽

Efficacy And Safety ◽

Real World Data ◽

World Data

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A real-world prospective observational study on the efficacy and safety of liposomal amphotericin B in 426 patients with persistent neutropenia and fever

Journal of Infection and Chemotherapy ◽

10.1016/j.jiac.2020.10.005 ◽

2020 ◽

Author(s):

Minoru Yoshida ◽

Kazuo Tamura ◽

Toru Masaoka ◽

Eiji Nakajo

Keyword(s):

Observational Study ◽

Amphotericin B ◽

Real World ◽

Liposomal Amphotericin ◽

Prospective Observational Study ◽

Liposomal Amphotericin B ◽

Efficacy And Safety

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P1.15-19 Treatment of Choice for First-Line Therapy of EGFR-Mutated Stage IIIB Lung Adenocarcinoma Based on the Real World Data

Journal of Thoracic Oncology ◽

10.1016/j.jtho.2018.08.951 ◽

2018 ◽

Vol 13 (10) ◽

pp. S619

Author(s):

S. Lu ◽

X. Ye ◽

D. Ding ◽

Z. Li ◽

X. Niu ◽

...

Keyword(s):

Lung Adenocarcinoma ◽

Real World ◽

Stage Iiib ◽

First Line ◽

Real World Data ◽

World Data ◽

The Real ◽

First Line Therapy ◽

Line Therapy ◽

Egfr Mutated

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A Real-World Analysis of Patients with Untreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Mutated Lung Adenocarcinoma Receiving First-Line Erlotinib and Bevacizumab Combination Therapy

Oncology and Therapy ◽

10.1007/s40487-021-00152-6 ◽

2021 ◽

Author(s):

Chin-Chou Wang ◽

Li-Chung Chiu ◽

Pi-Hung Tung ◽

Scott Chih-Hsi Kuo ◽

Chia-Hsun Chu ◽

...

Keyword(s):

Epidermal Growth Factor Receptor ◽

Growth Factor ◽

Epidermal Growth Factor ◽

Combination Therapy ◽

Lung Adenocarcinoma ◽

Real World ◽

Growth Factor Receptor ◽

First Line ◽

Epidermal Growth ◽

Egfr Mutated

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Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study

Dermatology ◽

10.1159/000511891 ◽

2020 ◽

pp. 1-8

Author(s):

Chunxia He ◽

Hongzhong Jin ◽

Xiguang Liu ◽

Fengming Hu ◽

Litao Zhang ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Plaque Psoriasis ◽

Adverse Reactions ◽

Response Rates ◽

The Body ◽

Betamethasone Dipropionate ◽

Efficacy And Safety ◽

Local Skin ◽

The Mean

Background: Topical agents are still the mainstay for the treatment of mild-to-moderate plaque psoriasis, in which fixed combinations play an important role. Tazarotene/betamethasone dipropionate (Taz/BD) cream is a novel fixed combination approved for treating plaque psoriasis in China, but its efficacy and safety have not been verified in a real-world environment. Objectives: The primary objective was to investigate the efficacy and safety of Taz/BD cream in treating plaque psoriasis. The secondary objectives were to assess its relapse after discontinuation and the efficacy and safety profiles during retreatment. Methods: A prospective, multicenter, large-scale observational study was conducted. Adult patients with chronic plaque psoriasis involving <20% of the body surface area were enrolled. Taz/BD cream was applied once daily for 4 weeks. Patients who achieved ≥90% improvement in the Psoriasis Area and Severity Index (PASI) from baseline to week 4 were followed up to investigate relapse after drug withdrawal. Relapsed patients underwent another 4-week treatment. Results: In total, 2,299 eligible patients were enrolled, and 2,095 patients (91.1%) completed the 4-week study. The mean PASI improvement at week 4 was 53.7%, and the PASI 50/75 response rates were 62.5 and 26.8%, respectively. The mean PASI reduction in plaque induration, desquamation and erythema were 58.3, 61.0 and 40.0%, respectively (p < 0.001). Adverse reactions occurred in 445 patients (20.8%) at week 4. The most frequently reported adverse reactions were local skin irritation, including pruritus (10%), pain (6.7%), erythema (6.1%) and desquamation (1.8%). During the post-treatment period, 47 patients (24.0%) relapsed within 8 weeks after drug discontinuation. Forty-five patients were retreated for another 4 weeks, and the PASI 50/75 response rates were 72.7 and 40.9%, respectively. There were no unexpected safety signals during retreatment. Conclusion: Taz/BD cream is effective and well tolerated in treating mild-to-moderate plaque psoriasis under near real-world conditions and demonstrates efficacy and safety during retreatment.

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