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3. Pathological chemotherapy response score is prognostic in tubo-ovarian high-grade serous carcinoma: A systematic review and meta-analysis of individual patient data

Author

Aggarwal, Simi, Bronger, Holger, Brown, Elizabeth B., Buck, Martin, Bukhari, Syed A., Coghlan, Edwina, Cope, Nichola, de Almeida, Michelle Samora, De Kroon, Cornelius D., Dean, Andrew, Devlin, Michael-John, Ditzel, Helena M., Drecoll, Enken, Ebata, Takahiro, Fagotti, Anna, Faruqi, Asma, Feeney, Laura, Gupta, Kavita, Harley, Ian, Inzani, Frediano, Jeyarajah, Arjun R., Koay, M.H. Eleanor, Kroep, Judith R., Lee, Jung-Yun, Leung, Yee, Lockley, Michelle, Loft, Alice R., MaGee, Daniel, Manchanda, Ranjit, McKenna, Sarah, Midha, Divya, Millan, David, Millar, Joanne, Miller, Rowan, Mohan, Ganendra R., Mughal, Sohail, Mukhopadhyay, Asima, Nicolau, Sergio Mancini, Nevin, James, Oakley, Abigail S., Quigley, Mary, Rai, Bhavana, Rajwanshi, Arvind, Salfinger, Stuart G., Scambia, Giovanni, Scatchard, Kate, Schmalfeldt, Barbara, Simcock, Bryony, Singh, Priya, Strickland, Kyle C., Suri, Vainta, Syed, Sheeba, Sykes, Peter, Tamura, Kenji, Tan, Adeline, Tan, Jason, Thompson, Emily, Tinker, Anna V., Trevisan, Georgia, Uyeda, Maria Gabriela Baumgarten Kuster, Vaughan, Michelle M., Weichert, Wilko, Williams, Anthony, Williams, Sarah, Yoshida, Hiroshi, Zorzato, Pier Carlo, Cohen, Paul A., Powell, Aime, Böhm, Steffen, Gilks, C. Blake, Stewart, Colin J.R., Meniawy, Tarek M., Bulsara, Max, Avril, Stefanie, Brockbank, Eleanor C., Bosse, Tjalling, de Azevedo Focchi, Gustavo Rubino, Ganesan, Raji, Glasspool, Rosalind M., Howitt, Brooke E., Kim, Hyun-Soo, Le, Nhu D., Mandalia, Trupti, McCluggage, W. Glenn, McNeish, Iain, Srinivasan, Radhika, Tan, Yun Yi, van der Griend, Rachael, Yunokawa, Mayu, Zannoni, Gian F., and Singh, Naveena

Published
2019
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6. Postchemotherapy Endometrioid to Gastrointestinal Histotype Shift in Recurrent Endometrial Carcinoma

Author

Arciuolo, Damiano, primary, Travaglino, Antonio, additional, Santoro, Angela, additional, Pedone Anchora, Luigi, additional, Inzani, Frediano, additional, Angelico, Giuseppe, additional, D’Alessandris, Nicoletta, additional, Scaglione, Giulia, additional, Valente, Michele, additional, Raffone, Antonio, additional, Fanfani, Francesco, additional, and Zannoni, Gian F., additional

Published
2021
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7. Corrigendum to “Pathological chemotherapy response score is prognostic in tubo-ovarian high-grade serous carcinoma: A systematic review and meta-analysis of individual patient data” Gynecol. Oncol. 154 (2019) 441–448

Author

Cohen, Paul A., primary, Powell, Aime, additional, Böhm, Steffen, additional, Gilks, C. Blake, additional, Stewart, Colin J.R., additional, Meniawy, Tarek M., additional, Bulsara, Max, additional, Avril, Stefanie, additional, Brockbank, Eleanor C., additional, Bosse, Tjalling, additional, de Azevedo Focchi, Gustavo Rubino, additional, Ganesan, Raji, additional, Glasspool, Rosalind M., additional, Howitt, Brooke E., additional, Kim, Hyun-Soo, additional, Lee, Jung-Yun, additional, Le, Nhu D., additional, Lockley, Michelle, additional, Manchanda, Ranjit, additional, Mandalia, Trupti, additional, McCluggage, W. Glenn, additional, McNeish, Iain, additional, Midha, Divya, additional, Srinivasan, Radhika, additional, Tan, Yun Yi, additional, van der Griend, Rachael, additional, Yunokawa, Mayu, additional, Zannoni, Gian F., additional, and Singh, Naveena, additional

Published
2021
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11. Corrigendum to “Pathological chemotherapy response score is prognostic in tubo-ovarian high-grade serous carcinoma: A systematic review and meta-analysis of individual patient data” [Gynecol. Oncol. 154 (2019) 441–448]

Author

Cohen, Paul A., primary, Powell, Aime, additional, Böhm, Steffen, additional, Gilks, C. Blake, additional, Stewart, Colin J.R., additional, Meniawy, Tarek M., additional, Bulsara, Max, additional, Avril, Stefanie, additional, Brockbank, Eleanor C., additional, Bosse, Tjalling, additional, de Azevedo Focchi, Gustavo Rubino, additional, Ganesan, Raji, additional, Glasspool, Rosalind M., additional, Howitt, Brooke E., additional, Kim, Hyun-Soo, additional, Lee, Jung-Yun, additional, Le, Nhu D., additional, Lockley, Michelle, additional, Manchanda, Ranjit, additional, Mandalia, Trupti, additional, McCluggage, W. Glenn, additional, McNeish, Iain, additional, Midha, Divya, additional, Srinivasan, Radhika, additional, Tan, Yun Yi, additional, van der Griend, Rachael, additional, Yunokawa, Mayu, additional, Zannoni, Gian F., additional, and Singh, Naveena, additional

Published
2020
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13. Pathological chemotherapy response score is prognostic in tubo-ovarian high-grade serous carcinoma: A systematic review and meta-analysis of individual patient data

Author

Cohen, Paul A., Powell, Aime, Böhm, Steffen, Gilks, C. Blake, Stewart, Colin J.R., Meniawy, Tarek M., Bulsara, Max, Avril, Stefanie, Brockbank, Eleanor C., Bosse, Tjalling, de Azevedo Focchi, Gustavo Rubino, Ganesan, Raji, Glasspool, Rosalind M., Howitt, Brooke E., Kim, Hyun-Soo, Lee, Jung-Yun, Le, Nhu D., Lockley, Michelle, Manchanda, Ranjit, Mandalia, Trupti, McCluggage, W. Glenn, McNeish, Iain, Midha, Divya, Srinivasan, Radhika, Tan, Yun Yi, van der Griend, Rachael, Yunokawa, Mayu, Zannoni, Gian F., Singh, Naveena, Aggarwal, Simi, Bronger, Holger, Brown, Elizabeth B., Buck, Martin, Bukhari, Syed A., Coghlan, Edwina, Cope, Nichola, de Almeida, Michelle Samora, De Kroon, Cornelius D., Dean, Andrew, Devlin, Michael-John, Ditzel, Helena M., Drecoll, Enken, Ebata, Takahiro, Fagotti, Anna, Faruqi, Asma, Feeney, Laura, Gupta, Kavita, Harley, Ian, Inzani, Frediano, Jeyarajah, Arjun R., Koay, M.H. Eleanor, Kroep, Judith R., Leung, Yee, Loft, Alice R., MaGee, Daniel, McKenna, Sarah, Millan, David, Millar, Joanne, Miller, Rowan, Mohan, Ganendra R., Mughal, Sohail, Nicolau, Sergio Mancini, Nevin, James, Oakley, Abigail S., Quigley, Mary, Rai, Bhavana, Rajwanshi, Arvind, Salfinger, Stuart G., Scambia, Giovanni, Scatchard, Kate, Schmalfeldt, Barbara, Simcock, Bryony, Singh, Priya, Strickland, Kyle C., Suri, Vainta, Syed, Sheeba, Sykes, Peter, Tamura, Kenji, Tan, Adeline, Tan, Jason, Thompson, Emily, Tinker, Anna V., Trevisan, Georgia, Uyeda, Maria Gabriela Baumgarten Kuster, Vaughan, Michelle M., Weichert, Wilko, Williams, Anthony, Williams, Sarah, Yoshida, Hiroshi, and Zorzato, Pier Carlo

Abstract

Objective:\ud There is a need to develop and validate biomarkers for treatment response and survival in tubo-ovarian high-grade serous carcinoma (HGSC). The chemotherapy response score (CRS) stratifies patients into complete/near-complete (CRS3), partial (CRS2), and no/minimal (CRS1) response after neoadjuvant chemotherapy (NACT). Our aim was to review current evidence to determine whether the CRS is prognostic in women with tubo-ovarian HGSC treated with NACT.\ud \ud Methods:\ud We established an international collaboration to conduct a systematic review and meta-analysis, pooling individual patient data from 16 sites in 11 countries. Patients had stage IIIC/IV HGSC, 3–4 NACT cycles and >6-months follow-up. Random effects models were used to derive combined odds ratios in the pooled population to investigate associations between CRS and progression free and overall survival (PFS and OS).\ud \ud Results:\ud 877 patients were included from published and unpublished studies. Median PFS and OS were 15 months (IQR 5–65) and 28 months (IQR 7–92) respectively. CRS3 was seen in 249 patients (28%). The pooled hazard ratios (HR) for PFS and OS for CRS3 versus CRS1/CRS2 were 0·55 (95% CI, 0·45–0·66; P

Published
2019

17. Ultrasound‐guided FNA cytology of groin lymph nodes improves the management of squamous cell carcinoma of the vulva: Results from a comparative cytohistological study

Author

Angelico, Giuseppe, primary, Santoro, Angela, additional, Inzani, Frediano, additional, Spadola, Saveria, additional, Fiorentino, Vincenzo, additional, Cianfrini, Federica, additional, Carbone, Claudia, additional, Garganese, Giorgia, additional, Rossi, Esther D., additional, Scambia, Giovanni, additional, and Zannoni, Gian F., additional

Published
2019
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18. One-Step Nucleic Acid Amplification (OSNA): A fast molecular test based on CK19 mRNA concentration for assessment of lymph-nodes metastases in early stage endometrial cancer

Author

Fanfani, Francesco, Monterossi, Giorgia, Ghizzoni, Viola, Rossi, Esther D., Dinoi, Giorgia, Inzani, Frediano, Fagotti, Anna, Gueli Alletti, Salvatore, Scarpellini, Francesca, Nero, Camilla, Santoro, Angela, Scambia, Giovanni, Zannoni, Gian Franco, Fanfani, Francesco (ORCID:0000-0003-1991-7284), Fagotti, Anna (ORCID:0000-0001-5579-335X), Alletti, Salvatore Gueli, Santoro, Angela (ORCID:0000-0002-6964-5152), Scambia, Giovanni (ORCID:0000-0003-2758-1063), Zannoni, Gian F. (ORCID:0000-0003-1809-129X), Fanfani, Francesco, Monterossi, Giorgia, Ghizzoni, Viola, Rossi, Esther D., Dinoi, Giorgia, Inzani, Frediano, Fagotti, Anna, Gueli Alletti, Salvatore, Scarpellini, Francesca, Nero, Camilla, Santoro, Angela, Scambia, Giovanni, Zannoni, Gian Franco, Fanfani, Francesco (ORCID:0000-0003-1991-7284), Fagotti, Anna (ORCID:0000-0001-5579-335X), Alletti, Salvatore Gueli, Santoro, Angela (ORCID:0000-0002-6964-5152), Scambia, Giovanni (ORCID:0000-0003-2758-1063), and Zannoni, Gian F. (ORCID:0000-0003-1809-129X)

Abstract

Introduction The aim of the current study is to evaluate the detection rate of micro- and macro-metastases of the One-Step Nucleic Acid Amplification (OSNA) compared to frozen section examination and subsequent ultra-staging examination in early stage endometrial cancer (EC). Material and methods From March 2016 to June 2016, data of 40 consecutive FIGO stage I EC patients were prospectively collected in an electronic database. The sentinel lymph node mapping was performed in all patients. All mapped nodes were removed and processed. Sentinel lymph nodes were sectioned and alternate sections were respectively examined by OSNA and by frozen section analysis. After frozen section, the residual tissue from each block was processed with step-level sections (each step at 200 micron) including H&E and IHC slides. Results Sentinel lymph nodes mapping was successful in 29 patients (72.5%). In the remaining 11 patients (27.5%), a systematic pelvic lymphadenectomy was performed. OSNA assay sensitivity and specificity were 87.5% and 100% respectively. Positive and negative predictive values were 100% and 99% respectively, with a diagnostic accuracy of 99%. As far as frozen section examination and subsequent ultra-staging analysis was concerned, we reported sensitivity and specificity of 50% and 94.4% respectively; positive and negative predictive values were 14.3% and 99%, respectively, with an accuracy of 93.6%. In one patient, despite negative OSNA and frozen section analysis of the sentinel node, a macro-metastasis in 1 non-sentinel node was found. Conclusions The combination of OSNA procedure with the sentinel lymph node mapping could represent an efficient intra-operative tool for the selection of early-stage EC patients to be submitted to systematic lymphadenectomy.

Published
2018

19. One-Step Nucleic Acid Amplification (OSNA): A fast molecular test based on CK19 mRNA concentration for assessment of lymph-nodes metastases in early stage endometrial cancer

Author

Fanfani, Francesco, primary, Monterossi, Giorgia, additional, Ghizzoni, Viola, additional, Rossi, Esther D., additional, Dinoi, Giorgia, additional, Inzani, Frediano, additional, Fagotti, Anna, additional, Gueli Alletti, Salvatore, additional, Scarpellini, Francesca, additional, Nero, Camilla, additional, Santoro, Angela, additional, Scambia, Giovanni, additional, and Zannoni, Gian F., additional

Published
2018
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20. Pathological Chemotherapy Response Score Predicts Survival in Patients with Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy: Systematic Review and Meta-Analysis of Individual Patient Data

Author

Cohen, Paul, primary, Powell, Aime, additional, Böhm, Steffen, additional, Gilks, C. Blake, additional, Stewart, Colin J.R., additional, Meniawy, Tarek M., additional, Bulsara, Max, additional, Avril, Stefanie, additional, Brockbank, Elly C., additional, Bosse, Tjalling, additional, Focchi, Gustavo Rubino de Azevedo, additional, Ganesan, Raji, additional, Glasspool, Rosalind M., additional, Howitt, Brooke E., additional, Kim, Hyun-Soo, additional, Lee, Jung-Yun, additional, Lee, Nhu D., additional, Lockley, Michelle, additional, Manchanda, Ranchit, additional, Mandalia, Trupti, additional, McCluggage, W. Glenn, additional, McNeish, Iain, additional, Midha, Divya, additional, Srinivasan, Radhika, additional, Tan, Yun Yi, additional, van der Griend, Rachael, additional, Yunokawa, Mayu, additional, Zannoni, Gian F., additional, Network, HGSC CRS Collaborative, additional, and Singh, Naveena, additional

Published
2018
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21. Biomarker analysis of the MITO2 phase III trial of first-line treatment in ovarian cancer: predictive value of DNA-PK and phosphorylated ACC

Author

Perrone, Francesco, primary, Baldassarre, Gustavo, additional, Indraccolo, Stefano, additional, Signoriello, Simona, additional, Chiappetta, Gennaro, additional, Esposito, Franca, additional, Ferrandina, Gabriella, additional, Franco, Renato, additional, Mezzanzanica, Delia, additional, Sonego, Maura, additional, Zulato, Elisabetta, additional, Zannoni, Gian F., additional, Canzonieri, Vincenzo, additional, Scambia, Giovanni, additional, Sorio, Roberto, additional, Savarese, Antonella, additional, Breda, Enrico, additional, Scollo, Paolo, additional, Ferro, Antonella, additional, Tamberi, Stefano, additional, Febbraro, Antonio, additional, Natale, Donato, additional, Maio, Massimo Di, additional, Califano, Daniela, additional, Scognamiglio, Giosuè, additional, Lorusso, Domenica, additional, Canevari, Silvana, additional, Losito, Simona, additional, Gallo, Ciro, additional, and Pignata, Sandro, additional

Published
2016
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22. Clear cell endometrial carcinoma and the TCGA classification.

Author

Travaglino, Antonio, Raffone, Antonio, Mascolo, Massimo, Guida, Maurizio, Insabato, Luigi, Zannoni, Gian F, and Zullo, Fulvio

Subjects
RENAL cell carcinoma, DNA mismatch repair, CLASSIFICATION
Abstract

We found that the most prevalent subgroups were the CNH subgroup (42.5%) and the CNL subgroup (40.9%), while the MSI subgroup (9.8%) and the POLE subgroup (3.8%) were less common (Figure). In fact, the CNL subgroup (also referred to as the "endometrioid" subgroup) typically includes hormone-responsive, low-grade endometrioid carcinomas, which have a good-to-intermediate prognosis.[1] Conversely, the CNH subgroup (also referred to as the "serous" subgroup) is mainly composed of serous carcinomas and bears the worst prognosis among all TCGA subgroups.[1] Therefore, it might be hypothesized that some CCCs are biologically similar to endometrioid carcinoma and have a better prognosis, while some are similar to serous carcinomas and have a poorer prognosis. Targeted molecular and immunohistochemical analyses of endometrial clear cell carcinoma show that POLE mutations and DNA mismatch repair protein deficiencies are uncommon. [Extracted from the article]

Published
2020
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24. Biomarker analysis of the MITO2 phase III trial of first-line treatment in ovarian cancer: Predictive value of DNA-PK and phosphorylated ACC

Author

Francesco Perrone, Gabriella Ferrandina, Giovanni Scambia, Roberto Sorio, Paolo Scollo, Maura Sonego, Silvana Canevari, Stefano Tamberi, Antonella Savarese, Elisabetta Zulato, Gennaro Chiappetta, Massimo Di Maio, Stefano Indraccolo, Antonio Febbraro, Simona Signoriello, Simona Losito, Sandro Pignata, Delia Mezzanzanica, Ciro Gallo, Franca Esposito, Enrico Breda, Gian Franco Zannoni, Antonella Ferro, Domenica Lorusso, Giosuè Scognamiglio, Renato Franco, Donato Natale, Daniela Califano, Gustavo Baldassarre, Vincenzo Canzonieri, Perrone, Francesco, Baldassarre, Gustavo, Indraccolo, Stefano, Signoriello, Simona, Chiappetta, Gennaro, Esposito, Franca, Ferrandina, Gabriella, Franco, Renato, Mezzanzanica, Delia, Sonego, Maura, Zulato, Elisabetta, Zannoni, Gian F, Canzonieri, Vincenzo, Scambia, Giovanni, Sorio, Roberto, Savarese, Antonella, Breda, Enrico, Scollo, Paolo, Ferro, Antonella, Tamberi, Stefano, Febbraro, Antonio, Natale, Donato, Di Maio, Massimo, Califano, Daniela, Scognamiglio, Giosue', Lorusso, Domenica, Canevari, Silvana, Losito, Simona, Gallo, Ciro, Pignata, Sandro, Zannoni, Gian F., Maio, Massimo Di, Scognamiglio, Giosuè, and DI MAIO, Massimo

Subjects
0301 basic medicine, medicine.medical_specialty, Liposomal Doxorubicin, ovarian cancer, phase 3 clinical trial, predictive factors, pACC, DNA-PK, DNA-Activated Protein Kinase, Disease-Free Survival, predictive factor, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Ovarian cancer, Phase 3 clinical trial, Antineoplastic Combined Chemotherapy Protocols, Overall survival, Medicine, Humans, Gynecology, Ovarian Neoplasms, Advanced ovarian cancer, business.industry, Significant difference, PACC, Predictive factors, Female, Prognosis, medicine.disease, Predictive value, Carboplatin, humanities, First line treatment, 030104 developmental biology, Oncology, chemistry, 030220 oncology & carcinogenesis, business, Research Paper
Abstract

// Francesco Perrone 1,* , Gustavo Baldassarre 2,* , Stefano Indraccolo 3,* , Simona Signoriello 4 , Gennaro Chiappetta 1 , Franca Esposito 5 , Gabriella Ferrandina 6 , Renato Franco 1,15 , Delia Mezzanzanica 7 , Maura Sonego 2 , Elisabetta Zulato 3 , Gian F. Zannoni 6 , Vincenzo Canzonieri 2 , Giovanni Scambia 6 , Roberto Sorio 2 , Antonella Savarese 8 , Enrico Breda 9 , Paolo Scollo 10 , Antonella Ferro 11 , Stefano Tamberi 12 , Antonio Febbraro 13 , Donato Natale 14 , Massimo Di Maio 1,16 , Daniela Califano 1 , Giosue Scognamiglio 1 , Domenica Lorusso 7 , Silvana Canevari 7 , Simona Losito 1 , Ciro Gallo 4,** and Sandro Pignata 1,** 1 Istituto Nazionale per lo Studio e la Cura dei Tumori - Fondazione G.Pascale, IRCCS, Napoli, Italy 2 Centro di Riferimento Oncologico, IRCCS, Aviano (PN), Italy 3 Istituto Oncologico Veneto, IRCCS, Padova, Italy 4 Dipartimento di Salute Mentale, Fisica e Medicina Preventiva, Statistica Medica, Seconda Universita, Napoli, Italy 5 Universita di Napoli Federico II, Napoli, Italy 6 Catholic University, Roma, Italy 7 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy 8 Istituto Nazionale Tumori Regina Elena, IRCCS, Roma, Italy 9 Ospedale S. Giovanni Calibita Fatebenefratelli, Roma, Italy 10 Ospedale Cannizzaro, Catania, Italy 11 Ospedale S. Chiara, Trento, Italy 12 Ospedale Civile, Faenza, Italy 13 Ospedale Fatebenefratelli, Benevento, Italy 14 Ospedale S. Massimo, Penne (PE), Italy 15 Dipartimento di Salute mentale, Fisica e Medicina Preventiva, Anatomia Patologica, Seconda Universita, Napoli Italy 16 Universita degli Studi, Torino, Italy * co-first author ** co-last author Correspondence to: Sandro Pignata, email: // Keywords : ovarian cancer, phase 3 clinical trial, predictive factors, pACC, DNA-PK Received : June 11, 2016 Accepted : August 03, 2016 Published : September 15, 2016 Abstract Background: No biomarker is available to predict prognosis of patients with advanced ovarian cancer (AOC) and guide the choice of chemotherapy. We performed a prospective-retrospective biomarker study within the MITO2 trial on the treatment of AOC. Patients and methods: MITO2 is a randomised multicentre phase 3 trial conducted with 820 AOC patients assigned carboplatin/paclitaxel (carboplatin: AUC5, paclitaxel: 175 mg/m², every 3 weeks for 6 cycles) or carboplatin/PLD-pegylated liposomal doxorubicin (carboplatin: AUC5, PLD: 30 mg/m², every 3 weeks for 6 cycles) as first line treatment. Sixteen biomarkers (pathways of adhesion/invasion, apoptosis, transcription regulation, metabolism, and DNA repair) were studied in 229 patients, in a tissue microarray. Progression-free and overall survival were analysed with multivariable Cox model. Results: After 72 months median follow-up, 594 progressions and 426 deaths were reported; there was no significant difference between the two arms in the whole trial. No biomarker had significant prognostic value. Statistically significant interactions with treatment were found for DNA-dependent protein kinase (DNA-PK) and phosphorylated acetyl-coenzymeA carboxylase (pACC), both predicting worse outcome for patients receiving carboplatin/paclitaxel. Conclusion: These data show that in presence of DNA-PK or pACC overexpression, carboplatin/paclitaxel might be less effective than carboplatin/PLD as first line treatment of ovarian cancer patients. Further validation of these findings is warranted.

Published
2016

25. Pathological chemotherapy response score is prognostic in tubo-ovarian high-grade serous carcinoma: A systematic review and meta-analysis of individual patient data.

Author

Cohen PA, Powell A, Böhm S, Gilks CB, Stewart CJR, Meniawy TM, Bulsara M, Avril S, Brockbank EC, Bosse T, de Azevedo Focchi GR, Ganesan R, Glasspool RM, Howitt BE, Kim HS, Lee JY, Le ND, Lockley M, Manchanda R, Mandalia T, McCluggage WG, McNeish I, Midha D, Srinivasan R, Tan YY, van der Griend R, Yunokawa M, Zannoni GF, and Singh N

Subjects
Antineoplastic Agents, Biomarkers, Tumor analysis, Disease-Free Survival, Fallopian Tube Neoplasms mortality, Fallopian Tube Neoplasms pathology, Female, Humans, Neoadjuvant Therapy, Neoplasms, Cystic, Mucinous, and Serous mortality, Neoplasms, Cystic, Mucinous, and Serous pathology, Ovarian Neoplasms mortality, Ovarian Neoplasms pathology, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin therapeutic use, Fallopian Tube Neoplasms drug therapy, Neoplasms, Cystic, Mucinous, and Serous drug therapy, Ovarian Neoplasms drug therapy
Abstract

Objective: There is a need to develop and validate biomarkers for treatment response and survival in tubo-ovarian high-grade serous carcinoma (HGSC). The chemotherapy response score (CRS) stratifies patients into complete/near-complete (CRS3), partial (CRS2), and no/minimal (CRS1) response after neoadjuvant chemotherapy (NACT). Our aim was to review current evidence to determine whether the CRS is prognostic in women with tubo-ovarian HGSC treated with NACT., Methods: We established an international collaboration to conduct a systematic review and meta-analysis, pooling individual patient data from 16 sites in 11 countries. Patients had stage IIIC/IV HGSC, 3-4 NACT cycles and >6-months follow-up. Random effects models were used to derive combined odds ratios in the pooled population to investigate associations between CRS and progression free and overall survival (PFS and OS)., Results: 877 patients were included from published and unpublished studies. Median PFS and OS were 15 months (IQR 5-65) and 28 months (IQR 7-92) respectively. CRS3 was seen in 249 patients (28%). The pooled hazard ratios (HR) for PFS and OS for CRS3 versus CRS1/CRS2 were 0·55 (95% CI, 0·45-0·66; P < 0·001) and 0·65 (95% CI 0·50-0·85, P = 0·002) respectively; no heterogeneity was identified (PFS: Q = 6·42, P = 0·698, I2 = 0·0%; OS: Q = 6·89, P = 0·648, I2 = 0·0%). CRS was significantly associated with PFS and OS in multivariate models adjusting for age and stage. Of 306 patients with known germline BRCA1/2 status, those with BRCA1/2 mutations (n = 80) were more likely to achieve CRS3 (P = 0·027)., Conclusions: CRS3 was significantly associated with improved PFS and OS compared to CRS1/2. This validation of CRS in a real-world setting demonstrates it to be a robust and reproducible biomarker with potential to be incorporated into therapeutic decision-making and clinical trial design., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2019
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