TEAM Study: Upfront Docetaxel Treatment in Patients With Metastatic Hormone-Sensitive Prostate Cancer: A Real-World, Multicenter, Retrospective Analysis.

BACKGROUND: Treatment of metastatic hormone-sensitive prostate cancer (mHSPC) dramatically changed. PEACE-1 and ARASENS trials established triplet therapy efficacy. Identifying prognostic factors supporting treatment choice is pivotal. METHODS: TEAM is an observational, retrospective study to evaluate prognostic role of variables in mHSPC patients receiving upfront docetaxel in 11 Italian centers. Outcome measures were progression-free survival (PFS) and overall-survival (OS). RESULTS: From September 2014 to December 2020, 147 patients were included. Median PFS and OS were 11.6 and 37.4 months. At univariate analysis, PFS-related variables were Gleason Score (GS) (P = .001), opioid use (P = .004), bone metastases number (P < .001), baseline PSA (P = .006), Hb (P < .001), ALP (P < .001) and LDH (P = .002), time between ADT and docetaxel start (P = .018), 3-month PSA (P < .001) and ALP (P < .001), and number of docetaxel cycles (P < .001). OS-related variables were PSA at diagnosis (P = .024), primary tumor treatment (P = .022), baseline pain (P = .015), opioid use (P < .001), bone metastases number (P < . 001), baseline Hb (P < .001), ALP (P < .001) and LDH (P = .001), NLR ratio (P = .039), 3-month PSA (P < .001) and ALP (P < .001) and docetaxel cycles number (P < .001). At multivariate analysis, independent prognostic variables were GS, opioid use, baseline LDH and time between ADT and docetaxel initiation for PFS, and baseline Hb and LDH for OS. CONCLUSION: Patients receiving upfront docetaxel with high GS, high disease burden, pain or opioid use, baseline unfavorable laboratory values had worse outcomes. Patients had greater docetaxel benefit when initiated early after ADT start. These parameters could be taken into account when selecting candidates for triplet therapy.

Comparison of endorectal magnetic resonance imaging, clinical prognostic factors and nomograms in the local staging of prostate cancer patients treated with radiotherapy.

AIMS AND BACKGROUND: To determine retrospectively the role of endorectal magnetic resonance in the staging of prostate cancer. The aim of the study was to assess whether it is possible to identify a group of patients with prostate cancer, chosen for certain prognostic factors, eligible for radiotherapy that could take advantage of endorectal magnetic resonance in staging and therapy management. METHODS: Between January 2002 and December 2005, 143 patients with biopsy proven prostate cancer underwent endorectal magnetic resonance. All patients were initially evaluated considering the following prognostic factors: serum prostate-specific antigen at diagnosis, Gleason score, histological grade, involvement of the seminal vesicle and extracapsular extension using the Roach III and ECE equations. The findings were then compared to the results of endorectal magnetic resonance. RESULTS: The relationship between the variable post-endorectal magnetic resonance stage modification and Gleason score was statistically significant (P = 0.02847). In addition, our study showed a statistically significant correlation between the risk of seminal vesicle involvement according to the Roach III formula and post-endorectal magnetic resonance stage modification (P = 0.01305). Conversely, statistical analysis showed no significant correlation between post-endorectal magnetic resonance stage modification and prostate-specific antigen values (P = 0.83440) or between post-endorectal magnetic resonance stage modification and the risk of extracapsular extension according to the extracapsular extension formula (P = 0.42748). CONCLUSIONS: Our data suggest that endorectal magnetic resonance could be used for staging of the subgroup of patients at high risk of seminal vesicle involvement (> 15%). Although we found a statistical correlation between Gleason score and post-endorectal magnetic resonance stage modification, statistical analysis showed no correlation between any of the subgroups. Therefore, it is not possible at the moment to identify a subgroup of patients by Gleason score that may benefit from endorectal magnetic resonance. In our opinion, extracapsular extension values were not useful to select patients for endorectal magnetic resonance.

Impact of concurrent radiotherapy on chemotherapy total dose and dose intensity in patients with early breast cancer.

AIMS AND BACKGROUND: A retrospective analysis was conducted to evaluate the tolerability as well as the impact of concurrent adjuvant CMF chemotherapy and radiation therapy on total CMF dose and dose intensity. METHODS: The medical records of 59 patients who had received conservative or radical surgery for breast cancer were analyzed. All patients had been assigned to 6 cycles of "1,8 CMF" adjuvant chemotherapy and concomitant radiation therapy. Total drug dose and dose intensity were calculated. Toxicity was recorded scored according to WHO criteria. RESULTS: A total of 355 cycles was administered. Fifty of 59 patients received at least 85% of the programmed chemotherapy total dose, the median value being 100% (range, 42-100). The median relative dose intensity was 0.97 (range, 0.42-1.01). Forty-four of 59 (75%) patients experienced grade 3-4 neutropenia (20 febrile neutropenia) and 29 (49%) required G-CSF support. CONCLUSIONS: This retrospective analysis showed that it is possible to give concurrent CMF and breast radiation while ensuring adequate chemotherapy total doses and dose intensities to most patients. However, G-CSF support is required in a significant proportion of patients.

Osteonecrosis of the jaw in prostate cancer patients with bone metastases treated with zoledronate: a retrospective analysis.

Osteonecrosis of the jaw (ONJ) has recently been reported as a potentially serious complication of prolonged treatment with intravenous bisphosphonates. We studied its frequency in prostate cancer patients receiving intravenous zoledronate. The medical and dental records of 52 consecutive patients with prostate cancer and bone metastases treated at our institute between January 2002 and October 2005 were reviewed. All patients received intravenous zoledronate 4 mg every 3 or 4 weeks and concomitant conventional prostate cancer treatments. We analysed the association of ONJ with the number of administrations of zoledronate and exposure to chemotherapy. At a median follow-up of 7 months (range 1-41) after the initiation of zoledronate, ONJ occurred in six patients (12%, 95% C.I. 5.4-23.0%). All six ONJ cases occurred after the 9(th) administration of zoledronate. The median number of zoledronate administrations was 17 (range 9-24) and 8 (range 1-32) for patient developing and not developing ONJ, respectively (p =0.02). Chemotherapy with docetaxel was also associated with a strong, but not statistically significant, trend towards increased risk of ONJ (OR 3.8, 95% C.I. 0.4-35.6, p =0.24). The length of exposure to zoledronate was associated with an increased frequency of ONJ in prostate cancer patients. A possible role of chemotherapy with docetaxel as a cofactor for ONJ merits further evaluation.