Abstract
Original language | English |
---|---|
Pages (from-to) | 142-149 |
Number of pages | 8 |
Journal | Gynecol. Oncol. |
Volume | 159 |
Issue number | 1 |
DOIs | |
Publication status | Published - 2020 |
Keywords
- Bevacizumab
- Carboplatin
- Cervical cancer
- Fistula
- Overall survival
- Perforation
- bevacizumab
- carboplatin
- paclitaxel
- adult
- advanced cancer
- aged
- alopecia
- anemia
- aortoduodenal fistula
- Article
- cancer radiotherapy
- chemoradiotherapy
- digestive system fistula
- digestive system perforation
- disease exacerbation
- drug efficacy
- drug withdrawal
- febrile neutropenia
- female
- follow up
- human
- hypertension
- major clinical study
- nausea
- neuropathy
- neutropenia
- overall survival
- peripheral neuropathy
- phase 2 clinical trial
- pneumothorax
- priority journal
- progression free survival
- proteinuria
- radiation response
- thrombocytopenia
- uterine cervix cancer
- vagina disease
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Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer : Gynecologic Oncology. / Redondo, A.; Colombo, N.; McCormack, M.; Dreosti, L.; Nogueira-Rodrigues, A.; Scambia, G.; Lorusso, D.; Joly, F.; Schenker, M.; Ruff, P.; Estevez-Diz, M.; Irahara, N.; Donica, M.; Gonzalez-Martín, A.
In: Gynecol. Oncol., Vol. 159, No. 1, 2020, p. 142-149.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer
T2 - Gynecologic Oncology
AU - Redondo, A.
AU - Colombo, N.
AU - McCormack, M.
AU - Dreosti, L.
AU - Nogueira-Rodrigues, A.
AU - Scambia, G.
AU - Lorusso, D.
AU - Joly, F.
AU - Schenker, M.
AU - Ruff, P.
AU - Estevez-Diz, M.
AU - Irahara, N.
AU - Donica, M.
AU - Gonzalez-Martín, A.
N1 - Cited By :1 Export Date: 5 March 2021 CODEN: GYNOA Correspondence Address: Redondo, A.; Department of Medical Oncology, Paseo de la Castellana 261, Spain; email: andres.redondos@uam.es Chemicals/CAS: bevacizumab, 216974-75-3, 1438851-35-4; carboplatin, 41575-94-4; paclitaxel, 33069-62-4 Funding details: F. Hoffmann-La Roche Funding text 1: The CECILIA study was sponsored by F Hoffmann-La Roche Ltd, Basel, Switzerland. The sponsor collaborated with the Steering Committee to design the study. The sponsor was involved in collection and analysis of data and interpretation of the results, together with the Steering Committee. Funding text 2: Andres Redondo, Nicoletta Colombo, Mary McCormack, Lydia Dreosti, Angelica Nogueira-Rodrigues, Natsumi Irahara, Margarita Donica, and Antonio Gonzalez-Martín contributed to the design of the trial and interpreted the results. Andres Redondo, Nicoletta Colombo, Mary McCormack, Lydia Dreosti, Angelica Nogueira-Rodrigues, Giovanni Scambia, Domenica Lorusso, Florence Joly, Michael Schenker, Paul Ruff, and Maria Estevez-Diz enrolled patients. Margarita Donica performed the statistical analyses. All authors critically reviewed the manuscript, which was drafted with the support of a medical writer funded by F Hoffmann-La Roche, and all authors provided final approval of the manuscript before submission. Funding text 3: We are grateful to the patients who participated in the trial, their families, the investigators and staff at participating centers, and Martina Schleifer, Stephen Robb, Lydie Bastière-Truchot, Youssef Ghazi, Bulent Ulker, and Nathalie Theron (current or former employees of F Hoffmann-La Roche Ltd, Basel). This study was sponsored and funded by F Hoffmann-La Roche Ltd , Basel, Switzerland. Medical writing assistance was provided by Jennifer Kelly, MA (Medi-Kelsey Ltd), funded by F Hoffmann-La Roche Ltd, Basel, Switzerland. References: McGraw, S.L., Ferrante, J.M., Update on prevention and screening of cervical cancer (2014) World J. Clin. Oncol., 5 (4), pp. 744-752; Shrestha, A.D., Neupane, D., Vedsted, P., Kallestrup, P., Cervical cancer prevalence, incidence and mortality in low and middle income countries: a systematic review (2018) Asian Pac. J. Cancer Prev., 19 (2), pp. 319-324; Cohen, P.A., Jhingran, A., Oaknin, A., Denny, L., Cervical cancer (2019) Lancet, 393 (10167), pp. 169-182; Tewari, K.S., Sill, M.W., Long, H.J., 3rd, Penson, R.T., Huang, H., Ramondetta, L.M., Landrum, L.M., Monk, B.J., Improved survival with bevacizumab in advanced cervical cancer (2014) N. Engl. J. 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Oncol., 33 (19), pp. 2129-2135; Burger, R.A., Brady, M.F., Bookman, M.A., Fleming, G.F., Monk, B.J., Huang, H., Mannel, R.S., Gynecologic Oncology Group, Incorporation of bevacizumab in the primary treatment of ovarian cancer (2011) N. Engl. J. Med., 365 (26), pp. 2473-2483; Perren, T.J., Swart, A.M., Pfisterer, J., Ledermann, J.A., Pujade-Lauraine, E., Kristensen, G., Carey, M.S., ICON7 Investigators, A phase 3 trial of bevacizumab in ovarian cancer (2011) N. Engl. J. Med., 365 (26), pp. 2484-2496; Iida, T., Muramatsu, T., Nakajima, R., Narayama, C., Narayama, T., Goya, K., Tsukada, H., Mikami, M., Recurrent cervical cancer with intestinal perforation that was related to bevacizumab after long-term NSAIDs administration and was treated with laparoscopy-assisted anastomosis (2019) Tokai J. Exp. Clin. 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Cancer, 24. , (29 (abstract IGCSM-1194)); Burger, R.A., Brady, M.F., Bookman, M.A., Monk, B.J., Walker, J.L., Homesley, H.D., Fowler, J., Liang, S.X., Risk factors for GI adverse events in a phase III randomized trial of bevacizumab in first-line therapy of advanced ovarian cancer: a Gynecologic Oncology Group Study (2014) J. Clin. Oncol., 32 (12), pp. 1210-1217; Roche, Primary Clinical Study Report – GOG-0240. GOG-0240 – a randomized phase III trial of cisplatin plus paclitaxel with and without NCI-supplied bevacizumab (NSC #704865, IND #113912) versus the non-platinum doublet, topotecan plus paclitaxel, with and without NCI-supplied bevacizumab, in stage IVB, recurrent or persistent carcinoma of the cervix – Report No. 1058089 (2014); Rosen, V.M., Guerra, I., McCormack, M., Nogueira-Rodrigues, A., Sasse, A., Munk, V.C., Shang, A., Systematic review and network meta-analysis of bevacizumab plus first-line topotecan-paclitaxel or cisplatin-paclitaxel versus non-bevacizumab-containing therapies in persistent, recurrent, or metastatic cervical cancer (2017) Int. J. Gynecol. Cancer, 27 (6), pp. 1237-1246; Kabbinavar, F.F., Flynn, P.J., Kozloff, M., Ashby, M.A., Sing, A., Barr, C.E., Grothey, A., Gastrointestinal perforation associated with bevacizumab use in metastatic colorectal cancer: results from a large treatment observational cohort study (2012) Eur. J. 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PY - 2020
Y1 - 2020
N2 - Objective: Adding bevacizumab to cisplatin–paclitaxel for advanced cervical cancer significantly improves overall and progression-free survival. We evaluated bevacizumab with a widely used carboplatin–paclitaxel backbone. Methods: Patients with metastatic/recurrent/persistent cervical cancer not amenable to curative surgery and/or radiotherapy received 3-weekly bevacizumab 15 mg/kg, paclitaxel 175 mg/m2, and carboplatin AUC 5 until progression or unacceptable toxicity. Maintenance bevacizumab was allowed. Patients with ongoing bladder/rectal involvement, prior cobalt radiotherapy, a history of fistula/gastrointestinal perforation, or recent bowel resection/chemoradiation were excluded. The primary objective was to determine incidences of gastrointestinal perforation/fistula, gastrointestinal-vaginal fistula, and genitourinary fistula. Results: Among 150 treated patients, disease at study entry was persistent in 21%, recurrent in 56%, and newly diagnosed metastatic in 23%. After 27.8 months' median follow-up, median bevacizumab duration was 6.7 months; 57% received maintenance bevacizumab. Seventeen patients (11.3%; 95% CI: 6.7–17.5%) experienced ≥1 perforation/fistula event: gastrointestinal perforation/fistula in 4.7% (1.9–9.4%), gastrointestinal-vaginal fistula in 4.0% (1.5–8.5%), and genitourinary fistula in 4.7% (1.9–9.4%). Of these, 16 were previously irradiated, several with ongoing radiation effects. The most common grade 3/4 adverse events were neutropenia (25%), anemia (19%), and hypertension (14%). Five patients (3%) had fatal adverse events. Objective response rate was 61% (95% CI: 52–69%), median progression-free survival was 10.9 (10.1–13.7) months, and median overall survival was 25.0 (20.9–30.4) months. Conclusions: Bevacizumab can be combined with carboplatin–paclitaxel in the CECILIA study population. The fistula/gastrointestinal perforation incidence is in line with GOG-0240; efficacy results are encouraging. Trial registration number. NCT02467907 (ClinicalTrials.gov). © 2020 Elsevier Inc.
AB - Objective: Adding bevacizumab to cisplatin–paclitaxel for advanced cervical cancer significantly improves overall and progression-free survival. We evaluated bevacizumab with a widely used carboplatin–paclitaxel backbone. Methods: Patients with metastatic/recurrent/persistent cervical cancer not amenable to curative surgery and/or radiotherapy received 3-weekly bevacizumab 15 mg/kg, paclitaxel 175 mg/m2, and carboplatin AUC 5 until progression or unacceptable toxicity. Maintenance bevacizumab was allowed. Patients with ongoing bladder/rectal involvement, prior cobalt radiotherapy, a history of fistula/gastrointestinal perforation, or recent bowel resection/chemoradiation were excluded. The primary objective was to determine incidences of gastrointestinal perforation/fistula, gastrointestinal-vaginal fistula, and genitourinary fistula. Results: Among 150 treated patients, disease at study entry was persistent in 21%, recurrent in 56%, and newly diagnosed metastatic in 23%. After 27.8 months' median follow-up, median bevacizumab duration was 6.7 months; 57% received maintenance bevacizumab. Seventeen patients (11.3%; 95% CI: 6.7–17.5%) experienced ≥1 perforation/fistula event: gastrointestinal perforation/fistula in 4.7% (1.9–9.4%), gastrointestinal-vaginal fistula in 4.0% (1.5–8.5%), and genitourinary fistula in 4.7% (1.9–9.4%). Of these, 16 were previously irradiated, several with ongoing radiation effects. The most common grade 3/4 adverse events were neutropenia (25%), anemia (19%), and hypertension (14%). Five patients (3%) had fatal adverse events. Objective response rate was 61% (95% CI: 52–69%), median progression-free survival was 10.9 (10.1–13.7) months, and median overall survival was 25.0 (20.9–30.4) months. Conclusions: Bevacizumab can be combined with carboplatin–paclitaxel in the CECILIA study population. The fistula/gastrointestinal perforation incidence is in line with GOG-0240; efficacy results are encouraging. Trial registration number. NCT02467907 (ClinicalTrials.gov). © 2020 Elsevier Inc.
KW - Bevacizumab
KW - Carboplatin
KW - Cervical cancer
KW - Fistula
KW - Overall survival
KW - Perforation
KW - bevacizumab
KW - carboplatin
KW - paclitaxel
KW - adult
KW - advanced cancer
KW - aged
KW - alopecia
KW - anemia
KW - aortoduodenal fistula
KW - Article
KW - cancer radiotherapy
KW - chemoradiotherapy
KW - digestive system fistula
KW - digestive system perforation
KW - disease exacerbation
KW - drug efficacy
KW - drug withdrawal
KW - febrile neutropenia
KW - female
KW - follow up
KW - human
KW - hypertension
KW - major clinical study
KW - nausea
KW - neuropathy
KW - neutropenia
KW - overall survival
KW - peripheral neuropathy
KW - phase 2 clinical trial
KW - pneumothorax
KW - priority journal
KW - progression free survival
KW - proteinuria
KW - radiation response
KW - thrombocytopenia
KW - uterine cervix cancer
KW - vagina disease
U2 - 10.1016/j.ygyno.2020.07.026
DO - 10.1016/j.ygyno.2020.07.026
M3 - Article
VL - 159
SP - 142
EP - 149
JO - Gynecol. Oncol.
JF - Gynecol. Oncol.
SN - 0090-8258
IS - 1
ER -