Corrigendum to “Complete pathological response following levonorgestrel intrauterine device in clinically stage 1 endometrial adenocarcinoma: Results of a randomized clinical trial” [Gynecologic Oncology 161 (2021) 143–151]

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

Download Full-text

Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

10.21203/rs.3.rs-51837/v2 ◽

2020 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

University Hospital ◽

Ca 125 ◽

European Medicines Agency ◽

Fertility Sparing ◽

Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

Download Full-text

A randomized clinical trial between ultrasound-guided and uterine sound-sparing approach for copper intrauterine device insertion

Fertility and Sterility ◽

10.1016/j.fertnstert.2019.07.159 ◽

2019 ◽

Vol 112 (3) ◽

pp. e9

Author(s):

Mohammed Khairy Ali ◽

Ahmed M. Abbas ◽

Asmaa Ramadan ◽

Ahmed M. Abdelmagied ◽

Mostafa Nasr Ibrahim ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intrauterine Device ◽

Ultrasound Guided ◽

Copper Intrauterine Device

Download Full-text

Misoprostol prior to inserting an intrauterine device in nulligravidas: a randomized clinical trial

Human Reproduction ◽

10.1093/humrep/det240 ◽

2013 ◽

Vol 28 (8) ◽

pp. 2118-2125 ◽

Cited By ~ 26

Author(s):

Adriana Scavuzzi ◽

Alex S.R. Souza ◽

Aurélio A.R. Costa ◽

Melania M.R. Amorim

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intrauterine Device

Download Full-text

CLO19-023: Induction Chemotherapy Followed by Chemoradiation and Trans-Anal Full Thickness Local Excision or Total Mesorectal Resection in Patients With T2-T3/NO-N+ Adenocarcinoma of the Rectum; Preliminary Results of Phase 2 Prospective Clinical Trial

Journal of the National Comprehensive Cancer Network ◽

10.6004/jnccn.2018.7249 ◽

2019 ◽

Vol 17 (3.5) ◽

pp. CLO19-023

Author(s):

Ahmed Abdalla ◽

Amr Aref ◽

Amer Alame ◽

Mohamad Barawi ◽

Danny Ma ◽

...

Keyword(s):

Clinical Trial ◽

Neoadjuvant Therapy ◽

Local Excision ◽

Pathological Response ◽

Phase Iii ◽

Prospective Clinical Trial ◽

Phase 2 ◽

Full Thickness ◽

Complete Pathological Response ◽

Mesorectal Resection

Background: The National Comprehensive Cancer Network (NCCN) Guidelines recently recognized total neoadjuvant therapy (TNT) as an acceptable option in patients with T3 and any N rectal cancer. Previous studies suggested that patients who received chemotherapy prior to conventional preoperative chemoradiation (CRT) and surgery allowed patients to receive more of their planned treatment with a better toxicity profile and increase in pathological response. However, those studies used a long course of FOLFOX or used capecitabine and oxaliplatin as an induction regimen. We are conducting a phase 2 prospective clinical trial to evaluate the use of 6 cycles of FOLFOX as TNT in patients with T2-T3/N0-N+. Patients and Methods: Patients with T2-T3/N0-N+ enrolled on our phase 2 prospective trial were included for this analysis. Patients received 6 cycles of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin), which was administered every 2 weeks. After 3 weeks of recovery period, patients then received conventional CRT with 5FU or capecitabine. All patients got MRI and endorectal ultrasound (ERUS) at baseline, after completing FOLFOX 3-months regimen and after finishing conventional CRT. Patients underwent either full-thickness local excision or total mesorectal resection depending on their tumor response to neoadjuvant therapy. The time interval between completion of radiation therapy and surgery ranged between 7and 12 weeks. Results: A total of 10 patients completed the chemotherapy and CRT treatment regimen. 9 patients proceeded to surgery and the 10th patient is scheduled for surgery. Clinical downstaging by MRI or ERUS was shown in 9 of 10 patients with only 6 cycles of FOLFOX. Complete clinical response was achieved in 6 patients as evident by ERUS/MRI of the pelvis after 3 months of FOLFOX before CRT. Complete pathological response was found in 4 of 9 patients (44%). In addition, 4 other patients had significant albeit not complete pathological response. Conclusions: This study suggests that adding only 6 cycles of neoadjuvant FOLFOX before CRT improved clinical and pathological downstaging of T2-T3/N0-N+ rectal adenocarcinoma and may facilitate organ preservation surgery. This is strategy needs to be investigated in larger phase III trials to validate these findings.

Download Full-text

Twelve weeks of resistance band exercise training improves age-associated hormonal decline, blood pressure, and body composition in postmenopausal women with stage 1 hypertension: a randomized clinical trial

Menopause ◽

10.1097/gme.0000000000001444 ◽

2019 ◽

Vol 27 (2) ◽

pp. 199-207 ◽

Cited By ~ 5

Author(s):

Won-Mok Son ◽

Elizabeth J. Pekas ◽

Song-Young Park

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Body Composition ◽

Exercise Training ◽

Postmenopausal Women ◽

Randomized Clinical Trial ◽

Stage 1

Download Full-text

Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial

10.20944/preprints201911.0010.v1 ◽

2019 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

Ca 125 ◽

Ultrasound Guided Puncture ◽

Guided Puncture ◽

Single Insertion

Background: Effectiveness of Anastrozole and levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis. Methods: Randomized clinical trial. Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and symptoms suggestive of endometriosis. Thirty-one women were randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration(TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months. CS or TUGPA one month after starting medical treatment. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole. For CA-125, the most significant decrease was observed without anastrozole. After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole, although anastrozole seems to delay recurrences. At 4,2±1,7 years, 88% of the patients who underwent CS were asymptomatic, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusion: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time.

Download Full-text