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1. ISOLATED INTESTINAL TUBERCULOSIS ASSOCIATED WITH HUMAN IMMUNODEFICIENCY VIRUS INFECTION

Author

Petru E. MUNTEAN

Subjects
human immunodeficiency virus, extrapulmonary tuberculosis, sign of fleischner, pneumonia with pneumocystis jirovecii, Medicine, Medicine (General), R5-920
Abstract

Introduction. Tuberculosis is a common and treatable human immunodeficiency virus-related (HIV) disease. Intestinal tuberculosis is much more recurrent in immunocompromised patients and presents as a complication of pulmonary tuberculosis due to swallow of infected sputum, hematogenic dissemination or even ingestion of contaminated milk. There is a strong need for close collaboration between HIV programmes and tuberculosis programmes. Case presentation. A 48-year-old male patient presented for a three month history of frequent bowel movements (3-4 stools per day, without blood or mucus), a weight loss of eight kilograms, infrequent dry cough, fatigue, esophageal candidiasis, anorexia, persistent low-grade fever and intermittent pain in the right lower abdominal quadrant. Abdominal X-Ray revealed a marked dilatation of the small intestine. High resolution axial computed tomography described thickening of the terminal ileum and medial caecal wall, with slightly enlarged low density nodes. Histopathological examination of the intestinal mucosa revealed granulomatous design and caseous necrosis. The positive diagnosis was primary extrapulmonary multidrug-resistant tuberculosis with HIV infection. He received an individualized and second line antituberculous treatment combined with antiretroviral therapy. Later on, he developed pneumonia with Pneumocystis jirovecii. The patient had a good clinical response to all therapies. Conclusions. Physicians should be aware that intestinal tuberculosis must be considered in the differential diagnosis of patients with abdominal symptoms, especially in immunocompromised patients.

Published
2020
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2. Pink eye – a symptom of COVID-19

Author

Petru E. MUNTEAN

Subjects
covid-19, sars-cov-2, pandemic, Medicine, Medicine (General), R5-920
Abstract

A 30-year-old male presented to the Emergency Department for a 3 day history of photophobia, redness and watery discharge from both of his eyes. The patient had no symptoms of fever, cough or dyspnea. His medical history was unremarkable and physical examination was normal. The patient mentioned that he is a dentist and that he wore personal protective equipment when having close contact with patients suffering from stomatological diseases, but on some particular events, he had to take off his protective eye-wear during certain interventions. In this instance, he can’t deny a possible contact with an asymptomatic case of COVID-19. The ophthalmology eye exam (Figure 1) with slit lamp examination described bilateral moderate conjunctival injection, inferior palpebral conjunctival follicles and bilateral watery discharge. Fundus examination disclosed unremarkable results. No subconjunctival haemorrhage or pseudomembranes. Macular ultrastructure or thickness assessed on optical coherence tomography were normal. No lesions on the corneal or anterior chamber. Routine fungal and bacterial cultures were also carried out and provided negative results. Oral and nasopharyngeal swab tests for SARS-CoV-2 were recommended, and came back negative. Nasal swab for influenza was also negative. Considering acute conjunctivitis, it was recommended to him to frequently clean the eyes by washing them with normal saline, to use cold compressions, topical anti-histaminics and frequent application of preservative free artificial tears. Also, a topical antibiotic was prescribed for 8 days. The patient was then discharged and recommended home isolation. After 36 hours, he was admitted to the hospital because of added complaints of cough and fever. Routine blood examination: glucose 113 mg/dL, C-reactive protein 13 mg/L, AST 43 U/L, ALT 73 U/L, LDH 313 U/L, monocytes% 14.3%, total cholesterol 223 mg/dL, triglycerides 234 mg/dL, a white blood cell count of 8.11 10^9/ Liter, neutrophils 5.76 10^9/Liter, lymphocytes 42.29%, D-dimers 487 ng/mL, creatine kinase-MB 17 U/L, fibrinogen 443 mg/dL, troponin T 7.11 ng/L, ferritin 179 ng/mL, erythrocyte sedimentation rate of 73 mm/hr, normal thrombin clotting time, creatinine clearance rate normal. Normal electrocardiogram. The computed tomography of the chest showed no signs of viral pneumonia (Figure 2). Samples for testing for SARS-CoV-2 were collected by conjunctival swab technique. The patient had positive RT-PCR results for both eye samples. Routine adenovirus tests returned negative results. To stop the evolution of COVID-19 infection, based on national protocol, the patient received the combination of lopinavir/ ritonavir (7 days), Heparin Sodium 5000 IU injection daily (7 days), cough syrup, hepatoprotectors, antacids, dexamethasone 20 mg tab daily (7 days), Azithromycin 500 mg tab daily (7 days). Other treatment was largely supportive. On day 8 of hospitalisation (day 12 of illness), the patient stated that all ocular symptoms had resolved. After hospital discharge, constant negative oropharyngeal swab tests for SARS-CoV-2 but serial conjunctival swab testing have shown that SARS-CoV-2 RNA may persist for up to 16 days, indicating a persistent replication of the 2019-nCoV.

Published
2020
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3. Successful recovery of COVID-19 pneumonia in a young male with negative COVID-19 IGM/IGG antibody rapid test but positive 2019-NCOV RT-PCR

Author

Petru E. MUNTEAN and Ana-M. MIHAI

Subjects
covid19, Medicine, Medicine (General), R5-920
Abstract

A 36-year-old man, chronic smoker (10 pack-year), with a history of sarcoid dermatitis at age 16 years, treated successfully, complains for seven days of persistent muscle pain, sore throat, cough with intermittent mucopurulent expectoration, right-sided chest pain, chills, high-grade fever, difficulty in breathing and a weight loss of 2 kilograms. Prior to hospital admission, he had close contact with his mother, who was declared 2019-nCoV positive, three days before his son’s symptoms appeared. At that particular moment, he was visited at home by his family physician and quickly assessed with chromatographic immunoassay for the qualitative detection of IgG & IgM antibody of COVID-19. The rapid test was non-reactive and the patient received symptomatic treatment. As an in-patient, upon physical inspection, we uncovered bibasilar crackles. Nasopharyngeal and oropharyngeal swabs tested positive by SARS-CoV-2 RT-PCR. Lab test results: glucose 119 mg/dL, a white blood cell count of 13.56 10^9/ Liter, neutrophils 8.95 10^9/Liter, lymphocytes 49.89%, D-dimers 0.519 ug/mL, creatine kinase-MB 25 U/L, lactic acid dehydrogenase (LDH) 722 U/L, fibrinogen 461 mg/dL, slightly elevated liver aminotranspherases, normal coagulation tests, normal renal function, angiotensin converting enzyme and calcium levels normal, troponin T 7.19 ng/L, ferritin 189 ng/mL, C reactive protein level of 21 ug/L and erythrocyte sedimentation rate of 30 mm/hr. Cardiac enzymes and electrocardiogram all normal. Rapid flu-test negative. The sputum sample was positive for Mycoplasma pneumoniae. High-resolution computed tomography (CT) of the chest disclosed few images of patchy ground glass opacities in bilateral lower lobes and minimal right-side pleural effusion (Figure 1). Based on the CT findings, the level of suspicion of COVID-19 infection is CO-RADS 6 (patient with positive PCR and bilateral ground glass opacities, halo sign, pleural fluid). Despite ultrasound-guided thoracentesis(1), the procedure was unsuccessful because of small effusion. The patient received for a short period low-dose methylprednisolone(2), cough medicines and, based on national protocol, 7 days of hydroxychloroquine in combination with azithromycin. The dynamics of chest high-resolution CT displayed structured absorption of lung lesions and no scarring of tissues (Figure 2)(3). After two negative RT-PCR tests from respiratory specimens at 24 hours interval and 17 days after onset of symptoms, he was considered clinically recovered and discharged. Oropharyngeal swab tests for COVID-19 in the follow-up visits were negative.

Published
2020
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4. Chest imaging features of COVID-19 pneumonia

Author

Petru E. MUNTEAN and Cristina G. NECULCEA

Subjects
covid-19, chest imaging, Medicine, Medicine (General), R5-920
Abstract

On 18th of April 2020, a 49-year-old woman developed a fever of 38.40C, with no other symptoms. After taking oral nonsteroidal anti-inflammatory agents for 2 days, the temperature returned to normal. On 20th of April 2020, she complained of persistent dry cough, sore throat, ageusia, anosmia and chest distress. The next day, she presented to the Emergency Department of Arges County Hospital, Pitesti, Romania. She divulged that she had been in close contact with a friend, who had been recently confirmed with the diagnosis of COVID-19. A high-resolution computed tomography (CT) of the chest was performed, that revealed multiple images of patchy ground-glass opacities in bilateral lower lobes (Figure 1). Given the close contact history and imaging findings, she was admitted as a suspected case of SARS-CoV-2 infection. On admission, physical examination unveiled normal vital signs, with oxygen saturation of 96% while breathing ambient air, lung auscultation normal. The antigen test for influenza was negative. Arterial blood gas analysis pointed out a pO2 of 103 mmHg, potassium 3.3 mEq/L, calcium 1.09 mmol/L and glucose 113 mg/dL. The blood routine tests revealed: white blood cell count 3.99 10^9/Liter, red blood cell count 6.41 10^12/Liter, hemoglobin 13.4 g/dL, hematocrit 40.1%, neutrophils 1.99 10^9/Liter, lymphocytes 39.9%, D-dimers 0.526 ug/mL, troponin T 7.22 ng/L, ferritin 192 ng/mL, procalcitonin 15 ug/L, creatine kinase-MB 27 U/L, lactic acid dehydrogenase (LDH) 481 U/L, fibrinogen 455 mg/dL, normal liver and renal function, normal prothrombin time. The electrocardiogram was normal. On 22th of April, the lab confirmed that the oropharyngeal swab test of SARS-CoV-2 by qualitative real-time reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay was positive. After seven days of symptomatic treatment and hydroxychloroquine therapy, the patient’s respiratory symptoms significantly improved. The dynamics of high-resolution CT of the chest revealed systematic absorption of lung lesions (Figure 2). After two consecutive (24 hours apart) oropharyngeal swab tests of SARS-CoV-2 RNA negative, the patient was discharged on 30th of April, with the indication for home quarantine for at least 14 days. SARS-CoV-2 RNA by oropharyngeal swab remained negative in the follow-up visit on 13th of May 2020. Take home messages: The accuracy of chest CT in symptomatic patients with COVID-19 is high, but used as a single diagnostic test, CT can not accurately diagnose or exclude coronavirus infection and should not be relied upon as a screening or diagnostic tool for COVID-19 pneumonia. Chest CT is rather helpful in evaluating the complications of COVID-19 and is indicated in patients with COVID-19 and worsening respiratory symptoms. The most common imaging findings are of an atypical or organising pneumonia, with bilateral involvement, especially of the lower lobes. Point of care lung ultrasound may be useful for the diagnosis and can detect abnormalities even in asymptomatic patients. The definitive diagnostic test for SARS-CoV-2 infection is the RT-PCR test.

Published
2020
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5. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., Lin H., Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., and Lin H.

Abstract

Background: At the time of AtTEnd trial design, standard treatment for advanced or recurrent endometrial cancer included carboplatin and paclitaxel chemotherapy. This trial assessed whether combining atezolizumab with chemotherapy might improve outcomes in this population. Methods: AtTEnd was a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial done in 89 hospitals in 11 countries across Europe, Australia, New Zealand, and Asia. Enrolled patients were aged 18 years or older, and had advanced or recurrent endometrial carcinoma or carcinosarcoma, an Eastern Cooperative Oncology Group performance status of 0–2, and received no previous systemic chemotherapy for recurrence. Patients were randomly assigned (2:1) using an interactive web response system (block size of six) to either atezolizumab 1200 mg or placebo given intravenously with chemotherapy (carboplatin at area under the curve of 5 or 6 and paclitaxel 175 mg/m2 intravenously on day 1 every 21 days) for 6–8 cycles, then continued until progression. Stratification factors were country, histological subtype, advanced or recurrent status, and mismatch repair (MMR) status. Participants and treating clinicians were masked to group allocation. The hierarchically tested co-primary endpoints were progression-free survival (in patients with MMR-deficient [dMMR] tumours, and in the overall population) and overall survival (in the overall population). Primary analyses were done in the intention-to-treat population, defined as all randomly assigned patients who gave their full consent to participation in the study and data processing. Safety was assessed in all patients included in the intention-to-treat population who received at least one dose of study treatment. Here, we report the primary progression-free survival and the interim overall survival results. This study is ongoing and is registered with ClinicalTrials.gov, NCT03603184. Findings: Between Oct 3, 2018, and Jan 7, 2022, 551 patients were r

Published
2024

7. Olaparib Addition to Maintenance Bevacizumab Therapy in Ovarian Carcinoma With BRCA-Like Genomic Aberrations

Author

Schouten, P, Schmidt, S, Becker, K, Thiele, H, Nürnberg, P, Richters, L, Ernst, C, Treilleux, I, Medioni, J, Heitz, F, Pisano, C, Garcia, Y, Petru, E, Hietanen, S, Colombo, N, Vergote, I, Nagao, S, Linn, S, Pujade-Lauraine, E, Ray-Coquard, I, Harter, P, Hahnen, E, Schmutzler, R, Schouten, Philip C, Schmidt, Sandra, Becker, Kerstin, Thiele, Holger, Nürnberg, Peter, Richters, Lisa, Ernst, Corinna, Treilleux, Isabelle, Medioni, Jacques, Heitz, Florian, Pisano, Carmela, Garcia, Yolanda, Petru, Edgar, Hietanen, Sakari, Colombo, Nicoletta, Vergote, Ignace, Nagao, Shoji, Linn, Sabine C, Pujade-Lauraine, Eric, Ray-Coquard, Isabelle, Harter, Philipp, Hahnen, Eric, Schmutzler, Rita K, Schouten, P, Schmidt, S, Becker, K, Thiele, H, Nürnberg, P, Richters, L, Ernst, C, Treilleux, I, Medioni, J, Heitz, F, Pisano, C, Garcia, Y, Petru, E, Hietanen, S, Colombo, N, Vergote, I, Nagao, S, Linn, S, Pujade-Lauraine, E, Ray-Coquard, I, Harter, P, Hahnen, E, Schmutzler, R, Schouten, Philip C, Schmidt, Sandra, Becker, Kerstin, Thiele, Holger, Nürnberg, Peter, Richters, Lisa, Ernst, Corinna, Treilleux, Isabelle, Medioni, Jacques, Heitz, Florian, Pisano, Carmela, Garcia, Yolanda, Petru, Edgar, Hietanen, Sakari, Colombo, Nicoletta, Vergote, Ignace, Nagao, Shoji, Linn, Sabine C, Pujade-Lauraine, Eric, Ray-Coquard, Isabelle, Harter, Philipp, Hahnen, Eric, and Schmutzler, Rita K

Abstract

Importance: Testing for homologous recombination deficiency is required for the optimal treatment of high-grade epithelial ovarian cancer. The search for accurate biomarkers is ongoing. Objective: To investigate whether progression-free survival (PFS) and overall survival (OS) of patients with high-grade epithelial ovarian cancer treated with maintenance olaparib or placebo differed between patients with a tumor BRCA-like genomic profile and patients without a tumor BRCA-like profile. Design, Setting, and Participants: This cohort study was a secondary analysis of the PAOLA-1 randomized clinical trial that compared olaparib plus bevacizumab with placebo plus bevacizumab as maintenance treatment in patients with advanced high-grade ovarian cancer after a good response to first-line platinum with taxane chemotherapy plus bevacizumab, irrespective of germline or tumor BRCA1/2 mutation status. All patients with available tumor DNA were included in the analysis. The current analysis tested for an interaction between BRCA-like status and olaparib treatment on survival outcomes. The original trial was conducted between July 2015 and September 2017; at the time of data extraction for analysis in March 2022, a median follow-up of 54.1 months (IQR, 28.5-62.2 months) and a total follow-up time of 21711 months was available, with 336 PFS and 245 OS events. Exposures: Tumor homologous recombination deficiency was assessed using the BRCA-like copy number aberration profile classifier. Myriad MyChoice CDx was previously measured. The trial was randomized between the olaparib and bevacizumab and placebo plus bevacizumab groups. Main Outcomes and Measures: This secondary analysis assessed hazard ratios (HRs) of olaparib vs placebo among biomarker strata and tested for interaction between BRCA-like status and olaparib treatment on PFS and OS, using Cox proportional hazards regression. Results: A total of 469 patients (median age, 60 [range 26-80] years) were included in this study. T

Published
2024

8. Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters—patient-centered end points in trials of maintenance therapy

Author

Friedlander, M., Rau, J., Lee, C.K., Meier, W., Lesoin, A., Kim, J.-W., Poveda, A., Buck, M., Scambia, G., Shimada, M., Hilpert, F., King, M.T., Debruyne, P., Bologna, A., Malander, S., Monk, B.J., Petru, E., Calvert, P., Herzog, T.J., Barrett, C., and du Bois, A.

Published
2018
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10. 123O Randomized phase II trial of neoadjuvant atezolizumab in combination with dual HER2 blockade plus epirubicin in early HER2-positive breast cancer (ABCSG-52/ATHENE)

Author

Rinnerthaler, G., primary, Egle, D., additional, Bartsch, R., additional, Schmitt, C.A., additional, Petzer, A.L., additional, Balic, M., additional, Petru, E., additional, Denison, U., additional, Singer, C.F., additional, Bjelic-Radisic, V., additional, Gampenrieder, S.P., additional, Knauer, M., additional, Posch, F., additional, Hlauschek, D., additional, Sölkner, L., additional, Bago-Horvath, Z.A., additional, Filipits, M., additional, Gili, M., additional, Gnant, M.I., additional, and Greil, R., additional

Published
2023
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13. Homologous Recombination Repair Gene Mutations to Predict Olaparib Plus Bevacizumab Efficacy in the First-Line Ovarian Cancer PAOLA-1/ENGOT-ov25 Trial

Author

Pujade-Lauraine, E, Brown, J, Barnicle, A, Wessen, J, Lao-Sirieix, P, Criscione, S, du Bois, A, Lorusso, D, Romero, I, Petru, E, Yoshida, H, Vergote, I, Colombo, N, Hietanen, S, Provansal, M, Schmalfeldt, B, Pignata, S, Martín Lorente, C, Berton, D, Runnebaum, I, Ray-Coquard, I, Pujade-Lauraine, Eric, Brown, Jessica, Barnicle, Alan, Wessen, Jonathan, Lao-Sirieix, Pierre, Criscione, Steven W, du Bois, Andreas, Lorusso, Domenica, Romero, Ignacio, Petru, Edgar, Yoshida, Hiroyuki, Vergote, Ignace, Colombo, Nicoletta, Hietanen, Sakari, Provansal, Magali, Schmalfeldt, Barbara, Pignata, Sandro, Martín Lorente, Cristina, Berton, Dominique, Runnebaum, Ingo B, Ray-Coquard, Isabelle, Pujade-Lauraine, E, Brown, J, Barnicle, A, Wessen, J, Lao-Sirieix, P, Criscione, S, du Bois, A, Lorusso, D, Romero, I, Petru, E, Yoshida, H, Vergote, I, Colombo, N, Hietanen, S, Provansal, M, Schmalfeldt, B, Pignata, S, Martín Lorente, C, Berton, D, Runnebaum, I, Ray-Coquard, I, Pujade-Lauraine, Eric, Brown, Jessica, Barnicle, Alan, Wessen, Jonathan, Lao-Sirieix, Pierre, Criscione, Steven W, du Bois, Andreas, Lorusso, Domenica, Romero, Ignacio, Petru, Edgar, Yoshida, Hiroyuki, Vergote, Ignace, Colombo, Nicoletta, Hietanen, Sakari, Provansal, Magali, Schmalfeldt, Barbara, Pignata, Sandro, Martín Lorente, Cristina, Berton, Dominique, Runnebaum, Ingo B, and Ray-Coquard, Isabelle

Abstract

Purpose: The PAOLA-1/ENGOT-ov25 trial of maintenance olaparib plus bevacizumab for newly diagnosed advanced high-grade ovarian cancer demonstrated a significant progression-free survival (PFS) benefit over placebo plus bevacizumab, particularly in patients with homologous recombination deficiency (HRD)-positive tumors. We explored whether mutations in non-BRCA1 or BRCA2 homologous recombination repair (non-BRCA HRRm) genes predicted benefit from olaparib plus bevacizumab in PAOLA-1. Methods: Eight hundred and six patients were randomly assigned (2:1). Tumors were analyzed using the Myriad MyChoice HRD Plus assay to assess non-BRCA HRRm and HRD status; HRD was based on a genomic instability score (GIS) of ≥ 42. In this exploratory analysis, PFS was assessed in patients harboring deleterious mutations using six non-BRCA HRR gene panels, three devised for this analysis and three previously published. Results: The non-BRCA HRRm prevalence ranged from 30 of 806 (3.7%) to 79 of 806 (9.8%) depending on the gene panel used, whereas 152 of 806 (18.9%) had non-BRCA1 or BRCA2 mutation HRD-positive tumors. The majority of tumors harboring non-BRCA HRRm had a low median GIS; however, a GIS of > 42 was observed for tumors with mutations in five HRR genes (BLM, BRIP1, RAD51C, PALB2, and RAD51D). Rates of gene-specific biallelic loss were variable (0% to 100%) in non-BRCA HRRm tumors relative to BRCA1-mutated (99%) or BRCA2-mutated (86%) tumors. Across all gene panels tested, hazard ratios for PFS (95% CI) ranged from 0.92 (0.51 to 1.73) to 1.83 (0.76 to 5.43). Conclusion: Acknowledging limitations of small subgroup sizes, non-BRCA HRRm gene panels were not predictive of PFS benefit with maintenance olaparib plus bevacizumab versus placebo plus bevacizumab in PAOLA-1, irrespective of the gene panel tested. Current gene panels exploring HRRm should not be considered a substitute for HRD determined by BRCA mutation status and genomic instability testing in first-line high-grade ov

Published
2023

14. Frühes Ovarialkarzinom (FIGO Stadium I–IIA)

Author

Petru, E., Benedicic, C., Kimmig, R., and Marth, C.

Abstract

Zusammenfassung: Etwa 25% der Ovarialkarzinome werden im FIGO-Stadium I, etwa 7% im Stadium IIA diagnostiziert. Die Verdachtsdiagnose eines Ovarialkarzinoms macht immer eine operative Abklärung mit histologischer Diagnosesicherung durch Laparotomie oder evtl. Laparoskopie notwendig, da es präoperativ unmöglich ist, mit halbwegs akzeptabler Sicherheit abzuschätzen, dass es sich um ein Frühstadium eines Ovarialkarzinoms handelt. Der Nachweis eines einzigen positiven Lymphknotens bedeutet, dass die Erkrankung einem FIGO-Stadium IIIc zuzuordnen ist. Im klinischen Stadium I oder II liegt in 31% tatsächlich ein höheres Stadium vor, da sich intraoperativ Metastasen im Omentum majus, Peritoneum oder den Lymphknoten finden. Die Primäroperation umfasst ein operatives Staging per Abdominallängsschnitt und eine Radikaloperation mit dem Ziel der Feststellung des Ausmaßes der Erkrankung sowie einer primären maximalen Tumorreduktion im Becken und Abdomen einschließlich pelviner und paraaortaler Lymphadenektomie. Ungünstige Prognosefaktoren beim FIGO-Stadium I sind v. a. eine intraoperative Kapselruptur und ein Grading G3.

Published
2024
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15. 32O 5-year (y) overall survival (OS) with maintenance olaparib (ola) plus bevacizumab (bev) by clinical risk in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) in the phase III PAOLA-1/ENGOT-ov25 trial

Author

Lorusso, D., primary, Mouret-Reynier, M-A., additional, Harter, P., additional, Cropet, C., additional, Caballero Diaz, C., additional, Petru, E., additional, Satoh, T., additional, Vergote, I.B., additional, Parma, G., additional, Jakobi Nøttrup, T., additional, Lebreton, C., additional, Fasching, P.A., additional, Pisano, C., additional, Manso, L., additional, Bourgeois, H., additional, Runnebaum, I., additional, Hardy-Bessard, A-C., additional, Schnelzer, A., additional, Pujade-Lauraine, E., additional, and Ray-Coquard, I.L., additional

Published
2023
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16. 23P Enriching for response: Patient selection criteria for A2AR inhibition by EXS-21546 through ex vivo modelling in primary patient material

Author

Vladimer, G., primary, Alt, I., additional, Sehlke, R., additional, Lobley, A., additional, Baumgärtler, C., additional, Stulic, M., additional, Hackner, K., additional, Dzurillova, L., additional, Petru, E., additional, Hadjari, L., additional, Lafleur, J., additional, Singer, J., additional, Krall, N., additional, Šufliarsky, J., additional, Hefler, L., additional, Fuereder, T., additional, Taubert, C., additional, Boudesco, C., additional, and Payne, A., additional

Published
2022
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17. Defining activity and patient selection of a novel CDK7 inhibitor, GTAEXS-617, through AI-supported primary cancer tissue profiling

Author

Somlyay, M., primary, Durinikova, E., additional, Besnard, J., additional, Barbeau, O., additional, Le Coz, J., additional, Senekowitsch, M., additional, Ergüner, B., additional, Hackner, K., additional, Dzurillova, L., additional, Petru, E., additional, Lafleur, J., additional, Singer, J., additional, Füreder, T., additional, Paveley, R., additional, Joseph, J., additional, Aswad, F., additional, Winkler-Penz, T., additional, Sehlke, R., additional, Boudesco, C., additional, and Vladimer, G., additional

Published
2022
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18. Adjuvant therapy of endometrial cancer

Author

Mallmann, P., Vordermark, D., Feyer, P., Hagen, V, Hoecht, S., Niehoff, P., Petru, E., Zeimet, A-G, Micke, O., Battista, M. J., Mallmann, P., Vordermark, D., Feyer, P., Hagen, V, Hoecht, S., Niehoff, P., Petru, E., Zeimet, A-G, Micke, O., and Battista, M. J.

Abstract

In July 2022, the first update (version 2.0) of the German S3 Guideline for the diagnostics, treatment and follow-up of patients with endometrial cancer was published, supported by the Leitlinienprogramm Onkologie (Guideline Program Oncology). This article is the summary of Chap. 7: Radiotherapy and of Chap, 8: Adjuvant systemic treatment. Relevant innovations compared to version 1.0 include the introduction of molecular classification, the impact of combined radio- and chemotherapy, the precise definition of the chemotherapy regime as well as the risk-dependent and stage-dependent flow charts of the adjuvant treatment options.

Published
2022

19. 195P REACH AUT: Efficacy and safety of first-line (1L) ribociclib (RIB) + endocrine therapy (ET) in HR+, HER2- metastatic breast cancer (MBC) from a real-world (RW) study: 3rd interim analysis

Author

Singer, C.F., primary, Egle, D., additional, Greil, R., additional, Petru, E., additional, Ohler, L., additional, Balic, M., additional, Tinchon, C., additional, Pfeiler, G., additional, Marhold, M., additional, Brunner, C., additional, Haider, K., additional, Galid, A., additional, Pluschnig, U., additional, Haslbauer, F., additional, Hubalek, M., additional, Redl, A., additional, Flatschacher, J., additional, Uthman, S., additional, Mraz, B., additional, and Bartsch, R., additional

Published
2022
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26. Trophoblasttumoren

Author

Petru, E., Kochli, O. R., Sevin, B.-U., Köchli, Ossi R., Sevin, Bernd-Uwe, Benz, Jörg, Petru, Edgar, and Haller, Urs

Published
1998
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34. Maligne epitheliale Tumoren des Corpus uteri

Author

Petru, E, Jonat, W, Fink, D, Köchli, O R, Petru, E ( E ), Jonat, W ( W ), Fink, D ( D ), Köchli, O R ( O R ), Imesch, P, Fehr, M, Petru, E, Jonat, W, Fink, D, Köchli, O R, Petru, E ( E ), Jonat, W ( W ), Fink, D ( D ), Köchli, O R ( O R ), Imesch, P, and Fehr, M

Published
2019

35. Radiotherapie bei gynäkologischen Tumoren

Author

Petru, E, Fink, D, Köchli, O R, Loibl, S, Petru, E ( E ), Fink, D ( D ), Köchli, O R ( O R ), Loibl, S ( S ), Linsenmeier, Claudia, Petru, E, Fink, D, Köchli, O R, Loibl, S, Petru, E ( E ), Fink, D ( D ), Köchli, O R ( O R ), Loibl, S ( S ), and Linsenmeier, Claudia

Abstract

Die Radiotherapie wird bei gynäkologischen Erkrankungen seit vielen Jahren erfolgreich angewendet. Mit modernen Radiotherapietechniken konnten die Nebenwirkungen deutlich reduziert werden. Die postoperative Radiotherapie beim brusterhaltend operierten Mammakarzinom ist fester Bestandteil der kurativen Therapie, neben Chemotherapie, Antikörpertherapie und/oder antihormoneller Therapie je nach Rezeptorstatus des Tumors. Hypofraktionierte (verkürzte) Schemata werden dabei zunehmend verwendet, was die Therapiedauer für die Patientinnen deutlich verkürzt – ohne Verlust an lokaler Kontrolle und mit sehr zufriedenstellender Kosmetik. Bei der Behandlung von Endometriumkarzinomen wird vor allem in der mittleren Risikogruppe die intravaginale Brachytherapie empfohlen, in der Hochrisikosituation die Kombination verschiedener Therapiemodalitäten. Die Brachytherapie hat auch in der kurativen Behandlung des fortgeschrittenen Zervixkarzinoms in Kombination mit perkutaner Bestrahlung und strahlensensibilisierender Chemotherapie seit vielen Jahren einen etablierten Platz.

Published
2019

36. Maligne nichtepitheliale Tumoren des Ovars

Author

Petru, E, Jonat, W, Fink, D, Köchli, O R, Petru, E ( E ), Jonat, W ( W ), Fink, D ( D ), Köchli, O R ( O R ), Fehr, M, Petru, E, Jonat, W, Fink, D, Köchli, O R, Petru, E ( E ), Jonat, W ( W ), Fink, D ( D ), Köchli, O R ( O R ), and Fehr, M

Published
2019

37. Maligne, nichtepitheliale Tumoren des Corupus uteri

Author

Petru, E, Jonat, W, Fink, D, Köchli, O R, Petru, E ( E ), Jonat, W ( W ), Fink, D ( D ), Köchli, O R ( O R ), Imesch, P, Petru, E, Jonat, W, Fink, D, Köchli, O R, Petru, E ( E ), Jonat, W ( W ), Fink, D ( D ), Köchli, O R ( O R ), and Imesch, P

Published
2019

38. Pan-European Expert Meeting on the Use of Metronomic Chemotherapy in Advanced Breast Cancer Patients: The PENELOPE Project

Author

Cazzaniga, M, Munzone, E, Bocci, G, Afonso, N, Gomez, P, Langkjer, S, Petru, E, Pivot, X, Sanchez Rovira, P, Wysocki, P, Torri, V, Cazzaniga M. E., Munzone E., Bocci G., Afonso N., Gomez P., Langkjer S., Petru E., Pivot X., Sanchez Rovira P., Wysocki P., Torri V., Cazzaniga, M, Munzone, E, Bocci, G, Afonso, N, Gomez, P, Langkjer, S, Petru, E, Pivot, X, Sanchez Rovira, P, Wysocki, P, Torri, V, Cazzaniga M. E., Munzone E., Bocci G., Afonso N., Gomez P., Langkjer S., Petru E., Pivot X., Sanchez Rovira P., Wysocki P., and Torri V.

Abstract

Introduction: Metronomic chemotherapy (mCHT) is a treatment regimen in which drugs are administered frequently or continuously and that maintains low, prolonged, and pharmacologically active plasma concentrations of drugs to avoid toxicity associated with traditional chemotherapy regimens, while achieving tumor response. Despite the increasing use of mCHT in patients with metastatic breast cancer (MBC) and the endorsement of mCHT in guidelines, no consensus exists about which patients may substantially benefit from mCHT, which agents can be recommended, and in which treatment setting mCHT is most appropriate. Methods: In October 2017, ten international experts in the management of breast cancer convened to develop a report describing the current status of the use of mCHT for the treatment of advanced breast cancer, based not only on current literature but also on their opinion. The Delphi method was used to reach consensus. Results: A full consensus was reached concerning the acknowledgement that mCHT is not simply a different way of administering chemotherapy but a truly new treatment option. The best-known effect of mCHT is on angiogenesis inhibition, but exciting new data are on the way regarding potential activity on immune system activation. The experts strongly suggest that the ideal patients for mCHT are those with hormone receptor (HR)-positive tumors or those with triple-negative disease. Independently of HR status, mCHT could be an advantageous option for elderly patients, who are often under-treated simply because of their age. Conclusion: Current data support the use of mCHT in selected patients with MBC. Funding: Pierre Fabre.

Published
2019

44. 203P Randomized study of single-agent metronomic versus weekly oral vinorelbine (VNR) as first-line chemotherapy in patients with HR+/HER2- advanced breast cancer

Author

Cazzaniga, M.E., primary, Martinez Jañez, N., additional, Kukielka-Budny, B.D., additional, Ulanska, M., additional, Bourgeois, H., additional, Muñoz Mateu, M., additional, Morales Murillo, S., additional, Bayo, J., additional, Cortesi, L., additional, Pinter, T., additional, Palacova, M., additional, Cherciu, N., additional, Petru, E., additional, Ettl, J., additional, De Almeida, C., additional, Raymond, R., additional, Villanova, G.R., additional, Thanh Minh, C. Ta, additional, Rodrigues, A.C.F., additional, and Freyer, G., additional

Published
2021
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45. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author

Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, Ristinge, S, Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, S Ristinge, Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, Ristinge, S, Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, and S Ristinge

Abstract

BACKGROUND Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinumbased chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival. RESULTS A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery. CONCLUSIONS In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overa

Published
2021

46. LBA40 Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma

Author

Colombo, N., Harano, K., Hudson, E., Galli, F., Antill, Y., Choi, C.H., Rabaglio, M., Marmé, F., Petru, E., Lai, C-H., Biagioli, E., Fariñas Madrid, L., Takehara, K., Allan, K., Lee, Y.C., Piovano, E., Zamagni, C., Tasca, G., Ferrero, A., and Barretina Ginesta, M.P.

Published
2023
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