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.

Anti-androgen therapy suspension following prolonged clinical and biochemical response: outcomes in a series of elderly patients with advanced prostate cancer.

AIMS AND BACKGROUND: To describe the outcomes following the suspension of androgen-suppression therapy in a series of elderly patients in an advanced stage of prostate cancer and in prolonged clinical and biochemical response. MATERIAL AND METHODS: Of 371 consecutive patients with advanced prostate cancer and treated with androgen-suppression therapy, 44 older patients were defined as in stable response on the basis of the following: absence of noteworthy dysuria, normal prostate findings on digital rectal examination, and prostate-specific antigen values lower than 0.50 ng/ml. After suspending treatment, it was to be re-scheduled in case of onset of dysuria, evidence of a palpable lesion on digital rectal examination, or a rise in prostate-specific antigen above 10 ng/ml. Progression of disease was defined as a prostate-specific antigen level increase at two subsequent measurements, and/or the appearance of new lesions, and/or evidence of progression of disease on digital rectal examination. RESULTS AND CONCLUSIONS: Median age of patients was 78.5 years at the moment of therapy suspension. After a median follow-up of 93.9 months, fourteen patients (31.8%) showed progression of disease, but only 7 (15.9%) of these died. In 7 (15.9%) patients, serum testosterone levels did not exceed 0.5 ng/ml, indicating an absence of gonadal activity. The median time to progression was 138.2 months, and the median cumulative survival from the start and from the suspension of androgen-suppression therapy was 105.5 months and 64.1 months, respectively. The savings in drug costs amounted to 772,267 Euro. Taking into consideration these outcomes of survival and of savings in drug costs, we can conclude that in these selected elderly patients, this treatment option could be of interest.

Capecitabine in combination with docetaxel and epirubicin in patients with previously untreated, advanced breast carcinoma.

BACKGROUND: The objective of this study was to evaluate the activity and safety of oral capecitabine in combination with docetaxel and epirubicin (TEX) as first-line treatment for patients with locally advanced/metastatic breast carcinoma. METHODS: This open-label, Phase II study was conducted at six Italian centers. Treatment consisted of epirubicin, 75 mg/m(2) (intravenous bolus), and docetaxel, 75 mg/m(2) (1-hour infusion), both administered on Day 1, plus oral capecitabine, 1000 mg/m(2) twice daily, on Days 1-14 of each 3-week treatment cycle. RESULTS: A total of 67 patients received 392 cycles of treatment, with a median of 6 cycles in patients with Stage III disease (n = 34 patients) and a median of 8 cycles in patients with Stage IV disease (n = 33 patients). The objective response rate was 82%, including complete responses in 21% of patients. A greater proportion of patients with Stage III disease achieved tumor responses compared with patients who had Stage IV disease (97% vs. 67%, respectively). Among 34 patients with Stage III disease, pathologic complete responses were confirmed in 10 patients (29%). TEX chemotherapy demonstrated an acceptable safety profile. There was a low incidence of Grade 3 adverse events, and Grade 4 adverse events were particularly rare (4%). The most common Grade 3-4 adverse event was febrile neutropenia, which occurred in 16% of patients. CONCLUSIONS: TEX combination therapy has important antitumor activity and an acceptable safety profile in this setting. A large, randomized, Phase III trial is ongoing to compare TEX chemotherapy with an epirubicin plus docetaxel regimen in patients with untreated, advanced breast carcinoma.