Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer

NCT ID: NCT05471427

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-07-01

Brief Summary

Aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged >/= 70 years old treated in our department, and explored association between baseline age, G8 score and Charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.

Detailed Description

Patients included in the analysis were affected by metastatic prostate cancer with >/=70 years old. All patients underwent Taxane treatment starting with standard treatment schedules (75 mg/m2 or 25 mg/m2 every 3 weeks, respectively). Chemotherapy with Docetaxel was scheduled for a total of 6-8 cicles in the mHSPC-mCRPC setting, respectively, and up to 9 cycles for Cabazitaxel treatment.

Indication to taxane chemotherapy was based on treating physician choice. G8 Questionnaires were collected before start and at the end of chemotherapy. Charlson comorbidity index was recorded for all patients before chemotherapy start. Data comprehensive of age, castrate resistant status , type of taxane used , Growth factors use during treatment, previous and following treatment with ARTAs or other taxanes, number of cycles administered, dose reductions , treatment suspension and treatment definitive interruptions unrelated to progressive disease, were collected and reported. Logistic regression was performed to explore the association between outcomes and baseline age, CCI and G8 score. Receiver Operating Characteristic curves analysis was performed to look for the optimal cut-off value for features significantly associated with treatment outcomes.

Conditions

Elderly Patients; Metastatic Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Taxane chemotherapy

Patients underwent taxane chemotherapy according to clinical practice for metastatic prostate cancer

Intervention Type: DRUG

Other Intervention Names

Docetaxel or Cabazitaxel

Eligibility Criteria

Inclusion Criteria

• Patients affected by metastatic prostate cancer

->/=70 years old.

• Patients undergoing Taxane treatment with Docetaxel or Cabazitaxel

Exclusion Criteria

• Patients younger than 70 years old.
• Patients unsuitable for taxane chemotherapy

• Minimum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Livi

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo LL Livi

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria Careggi

Locations

AOU Careggi Radiation Oncology Unit

Florence, , Italy

Countries

Italy

References

Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. doi: 10.1200/JCO.2007.12.4008.

Reference Type: BACKGROUND

PMID: 18182665 (View on PubMed)

de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

Reference Type: BACKGROUND

PMID: 20888992 (View on PubMed)

Kyriakopoulos CE, Chen YH, Carducci MA, Liu G, Jarrard DF, Hahn NM, Shevrin DH, Dreicer R, Hussain M, Eisenberger M, Kohli M, Plimack ER, Vogelzang NJ, Picus J, Cooney MM, Garcia JA, DiPaola RS, Sweeney CJ. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.

Reference Type: BACKGROUND

PMID: 29384722 (View on PubMed)

James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, Ritchie AW, Parker CC, Russell JM, Attard G, de Bono J, Cross W, Jones RJ, Thalmann G, Amos C, Matheson D, Millman R, Alzouebi M, Beesley S, Birtle AJ, Brock S, Cathomas R, Chakraborti P, Chowdhury S, Cook A, Elliott T, Gale J, Gibbs S, Graham JD, Hetherington J, Hughes R, Laing R, McKinna F, McLaren DB, O'Sullivan JM, Parikh O, Peedell C, Protheroe A, Robinson AJ, Srihari N, Srinivasan R, Staffurth J, Sundar S, Tolan S, Tsang D, Wagstaff J, Parmar MK; STAMPEDE investigators. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1163-77. doi: 10.1016/S0140-6736(15)01037-5. Epub 2015 Dec 21.

Reference Type: BACKGROUND

PMID: 26719232 (View on PubMed)

Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.

Reference Type: BACKGROUND

PMID: 23306100 (View on PubMed)

Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.

Reference Type: BACKGROUND

PMID: 35179323 (View on PubMed)

Boyle HJ, Alibhai S, Decoster L, Efstathiou E, Fizazi K, Mottet N, Oudard S, Payne H, Prentice M, Puts M, Aapro M, Droz JP. Updated recommendations of the International Society of Geriatric Oncology on prostate cancer management in older patients. Eur J Cancer. 2019 Jul;116:116-136. doi: 10.1016/j.ejca.2019.04.031. Epub 2019 Jun 10.

Reference Type: BACKGROUND

PMID: 31195356 (View on PubMed)

Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.

Reference Type: BACKGROUND

PMID: 22250183 (View on PubMed)

Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.

Reference Type: BACKGROUND

PMID: 21330339 (View on PubMed)

Horgan AM, Seruga B, Pond GR, Alibhai SM, Amir E, De Wit R, Eisenberger MA, Tannock IF. Tolerability and efficacy of docetaxel in older men with metastatic castrate-resistant prostate cancer (mCRPC) in the TAX 327 trial. J Geriatr Oncol. 2014 Apr;5(2):119-26. doi: 10.1016/j.jgo.2013.12.001. Epub 2014 Jan 2.

Reference Type: BACKGROUND

PMID: 24495703 (View on PubMed)

Della Pepa C, Cavaliere C, Rossetti S, Di Napoli M, Cecere SC, Crispo A, De Sangro C, Rossi E, Turitto D, Germano D, Iovane G, Berretta M, D'Aniello C, Pisconti S, Maiorino L, Daniele B, Gridelli C, Pignata S, Facchini G. Predictive Comprehensive Geriatric Assessment in elderly prostate cancer patients: the prospective observational scoop trial results. Anticancer Drugs. 2017 Jan;28(1):104-109. doi: 10.1097/CAD.0000000000000428.

Reference Type: BACKGROUND

PMID: 27579728 (View on PubMed)

Gerritse FL, Meulenbeld HJ, Roodhart JM, van der Velden AM, Blaisse RJ, Smilde TJ, Erjavec Z, de Wit R, Los M; NePro Study Investigators. Analysis of docetaxel therapy in elderly (>/=70 years) castration resistant prostate cancer patients enrolled in the Netherlands Prostate Study. Eur J Cancer. 2013 Oct;49(15):3176-83. doi: 10.1016/j.ejca.2013.06.008. Epub 2013 Jul 9.

Reference Type: BACKGROUND

PMID: 23849828 (View on PubMed)

Maia MC, Pereira AAL, Lage LV, Fraile NM, Vaisberg VV, Kudo G, Barroso-Sousa R, Bastos DA, Dzik C. Efficacy and Safety of Docetaxel in Elderly Patients With Metastatic Castration-Resistant Prostate Cancer. J Glob Oncol. 2018 Sep;4:1-9. doi: 10.1200/JGO.2016.007807. Epub 2017 Mar 27.

Reference Type: BACKGROUND

PMID: 30241182 (View on PubMed)

Shayegan B, Wallis CJD, Hamilton RJ, Morgan SC, Cagiannos I, Basappa NS, Ferrario C, Gotto GT, Fernandes R, Roy S, Noonan KL, Niazi T, Hotte SJ, Saad F, Hew H, Park-Wyllie L, Chan KFY, Malone S. Real-world utilization and outcomes of docetaxel among older men with metastatic prostate cancer: a retrospective population-based cohort study in Canada. Prostate Cancer Prostatic Dis. 2023 Mar;26(1):74-79. doi: 10.1038/s41391-022-00514-9. Epub 2022 Feb 23.

Reference Type: BACKGROUND

PMID: 35197558 (View on PubMed)

Italiano A, Ortholan C, Oudard S, Pouessel D, Gravis G, Beuzeboc P, Bompas E, Flechon A, Joly F, Ferrero JM, Fizazi K. Docetaxel-based chemotherapy in elderly patients (age 75 and older) with castration-resistant prostate cancer. Eur Urol. 2009 Jun;55(6):1368-75. doi: 10.1016/j.eururo.2008.07.078. Epub 2008 Aug 8.

Reference Type: BACKGROUND

PMID: 18706755 (View on PubMed)

Takaha N, Okihara K, Kamoi K, Hongo F, Iwata T, Yano K, Ueda T, Takeuchi I, Yamada T, Kawauchi A, Miki T. Feasibility of tri-weekly docetaxel-based chemotherapy for elderly patients (age 75 and older) with castration-resistant prostate cancer. Urol Int. 2011;87(3):263-9. doi: 10.1159/000328217. Epub 2011 Aug 26.

Reference Type: BACKGROUND

PMID: 21876321 (View on PubMed)

Wang KY, Ma L, Zhang LL, Hu YC, Jiang JH, Ma Q. Efficacy and safety of docetaxel and prednisolone chemotherapy in very elderly men with metastatic castration-resistant prostate cancer (mCRPC) in real world: a single institute experience. Ann Palliat Med. 2021 Feb;10(2):1438-1444. doi: 10.21037/apm-20-573a. Epub 2020 Oct 15.

Reference Type: BACKGROUND

PMID: 33081478 (View on PubMed)

Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; PROSTY study group. 2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. doi: 10.1016/S1470-2045(12)70537-5. Epub 2013 Jan 4.

Reference Type: BACKGROUND

PMID: 23294853 (View on PubMed)

Sternberg CN, Castellano D, de Bono J, Fizazi K, Tombal B, Wulfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdottir A, Theodore C, Feyerabend S, Helissey C, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, de Wit R. Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study. Eur Urol. 2021 Oct;80(4):497-506. doi: 10.1016/j.eururo.2021.06.021. Epub 2021 Jul 15.

Reference Type: BACKGROUND

PMID: 34274136 (View on PubMed)

Other Identifiers

ANCHISES

Identifier Type: -

Identifier Source: org_study_id