Use of cat's claw might be beneficial in patients with advanced cancer by improving their quality of life and reducing fatigue. The mechanism of action does not seem to be related to the anti-inflammatory properties of this plant.

Background Testosterone suppression is the standard treatment for advanced prostate cancer, and it is associated with side-effects that impair patients’ quality of life, like sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk. We hypothesized that abiraterone acetate with prednisone (AAP) and apalutamide, alone or in combination, can be an effective hormonal therapy also possibly decreasing castration-associated side effects. Methods Phase II, open-label, randomized, efficacy trial of abiraterone acetate plus prednisone (AAP) and Androgen Deprivation Therapy (ADT) versus apalutamide versus the combination of AAP (without ADT) and apalutamide. Key eligibility criteria are confirmed prostate adenocarcinoma; biochemical relapse after definitive treatment (PSA ≥ 4 ng/ml and doubling time less than 10 months, or PSA ≥ 20 ng/ml); newly diagnosed locally advanced or metastatic prostate cancer; asymptomatic to moderately symptomatic regarding bone symptoms. Patients with other histology besides adenocarcinoma or previous use of hormonal therapy or chemotherapy were excluded. Discussion There is an urgent need to study and validate regimens such as new hormonal agents that may add benefit to castration with an acceptable safety profile. We aim to evaluate if apalutamide in monotherapy or in combination with AAP is an effective and safety hormonal treatment that can spare patients of androgen deprivation therapy. Trial registration This trial was registered in ClinicalTrials.gov on October 16, 2017, under Identifier: NCT02867020.

We propose that guarana is not beneficial for this patient population.

5505 Background: ADT combined with AAP, APA, enzalutamide or docetaxel are among the standard treatment options to patients (pts) with hormone sensitive advanced/metastatic prostate cancer (PC). However, treatment-related adverse events (TRAEs) due to ADT impact negatively on the quality of life of these patients. Effective options with fewer TRAEs are required. Methods: LACOG 0415 is a phase II, randomized trial (1:1:1) evaluating the use of AA 1000mg po + prednisone 5mg po BID + ADT versus APA 240mg po alone versus AA 1000mg po + prednisone 5mg po BID + APA 240mg po in patients with advanced PC with non-castrate testosterone levels and indication of ADT (N+ or M+ or biochemical relapse combined with PSA ≥ 20 ng/ml or with PSA≥4 ng/ml and PSA doubling-time < 10 months). Stratification factors: metastatic disease (+/-). Primary endpoint was the percentage of pts who achieved PSA ≤ 0.2 ng/mL at Week 25, we estimated a PSA response rate of 65% in each of the three arms with a null hypothesis of 45%, power of 80% and alfa 5%, using Fleming one-stage method. Secondary endpoints were percentage of pts with ≥ 80% and ≥ 50% decline in PSA at week 25, radiographic progression-free survival (rPFS) and safety. Results: 128 patients were randomized between Oct 2017 and Apr 2019, and 122 pts were evaluable for PSA response. Median age was 69y (range, 53-88); most pts had ECOG PS0-1(99%). 17% of pts had biochemical relapse only, 9% N+ and 74% M+ disease. At week 25 the PSA was ≤ 0.2 ng/mL in 76% of pts in AAP+ADT arm, 59% in APA, and 80% in APA+AAP. All pts had a decline of ≥ 50% in PSA at week 25. 97% had a decline of ≥ 80% in PSA at week 25: 100% of pts in AAP+ADT arm, 95% in APA and 98% in APA+AAP. A total of 3 pts had clinical progressive disease, one in each arm. Two of them also had radiological progression at week 25, 1 pt in AAP+ADT arm and 1 pt in APA. TRAEs rates of any grade were 71% in AAP+ADT arm, 64% in APA, and 65% in APA+AAP. TRAEs rates of Grade≥3 were 12% in AAP+ADT arm, 9% in APA and 16% in APA+AAP. 9 pts (7%) discontinued the treatment before the week 25, 5(4%) of them due to toxicity: 1 pt from AAP+ADT, 2 pts from APA, and 6 pts from APA+AAP. Conclusions: The AAP+ADT and APA+AAP groups showed high effectiveness in terms of PSA response. Radiologic disease control and the decline of ≥ 80% in PSA at week 25 were similar among all treatment arms. APA alone had less toxicity. APA+AAP and APA alone are promising regimens in this setting. No new safety signal was detected in the study. Clinical trial information: NCT02867020 .

PURPOSE Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a complex treatment. In Brazil, as in most developing countries, data are scarce, but mortality seems exceedingly high. We have created a centralization program involving a multidisciplinary clinic in a region comprising seven municipalities. The aim of this study is to evaluate the impact of a multidisciplinary clinic and a centralization-of-care program (CABEM program) on MIBC treatment in Brazil. PATIENTS AND METHODS A total of 116 consecutive patients were evaluated. In group 1, 58 patients treated for MIBC before establishing a bladder cancer program from 2011 to 2017 were retrospectively evaluated. Group 2 represented 58 patients treated for MIBC after the implementation of the CABEM centralization program. Age, sex, staging, comorbidity indexes, mortality rates, type of treatment, and perioperative outcomes were compared. RESULTS Patients from group 2 versus 1 were older (68 v 64.2 years, P = .02) with a higher body mass index (25.5 v 22.6 kg/m2, P = .017) and had more comorbidities according to both age-adjusted Charlson Comorbidity Index (4.2 v 2.8, P = .0007) and Isbarn index (60.6 v 43.9, P = .0027). Radical cystectomy (RC) was the only treatment modality for patients in group 1, whereas in group 2, there were 31 (53%) RC; three (5%) partial cystectomies; seven (12%) trimodal therapies; 13 (22%) palliative chemotherapies; and three (5%) exclusive transurethral resections of the bladder tumor. No patient in group 1 received neoadjuvant chemotherapy, whereas it was offered to 69% of patients treated with RC. Ninety-day mortality rates were 34.5% versus 5% for groups 1 versus 2 ( P < .002). One-year mortality was also lower in group 2. CONCLUSION Our data support that a centralization program, a structured bladder clinic associated with protocols, a multidisciplinary team, and inclusion of chemotherapy and radiotherapy treatments can pleasingly improve outcomes for patients with MIBC.

Background: Androgen deprivation therapy (ADT) combined with apalutamide, abiraterone acetate plus prednisone, enzalutamide, or docetaxel are the standard treatments for advanced castration-sensitive prostate cancer (CSPC). We investigated ADT-free alternatives for advanced CSPC. Patients and methods: LACOG 0415 is a phase 2, open-label, non-comparative, randomized trial. Patients with advanced CSPC were randomized (1:1:1) to receive goserelin plus abiraterone acetate and prednisone (ADT plus AAP arm), apalutamide (APA arm), or apalutamide plus abiraterone acetate and prednisone (APA plus AAP arm). The primary endpoint was the proportion of patients with PSA of 0.2 ng/mL at week 25 in the modified intentionto-treat population. Safety analyses were performed in all patients with at least one dose of the study drug. Results: Of 128 randomized patients, 120 patients were evaluable for PSA response at week 25; 17.2% had a high-risk biochemical recurrence, 8.6% had locally advanced disease, and 74.2% had distant metastases. At week 25, PSA of 0.2 ng/mL was observed in 75.6% (95%CI 59.7%e87.6%), 60.0% (95%CI 43.3%e75.1%), and 79.5% (95%CI 63.5%e90.7%) of patients in ADT plus AAP, APA, and APA plus AAP arms, respectively. PSA decline of !80% was observed in 100%, 90.0%, and 97.4%, respectively. Grade 3e4 AEs were observed in 31.0%, 21.4% and 36.4%, respectively. Testosterone levels increased significantly in the APA arm and decreased significantly in ADT plus AAP and APA plus AAP arms. Conclusions: ADT-free alternatives provide a high PSA response in advanced CSPC, although the APA arm did not reach the expected rate of PSA of 0.2 ng/mL at week 25. These results warrant further investigation of ADT-free treatments as alternatives in advanced CSPC. Source study registration: ClinicalTrials.gov NCT02867020.

e16568 Background: The Quality Oncology Practice Initiative (QOPI) is a voluntary program developed by ASCO to aid oncology practices in quality self-assessment and continuous improvement of patient records. It consists of a cyclical, semiannual measurement of the adequacy of several care processes pertaining to some important aspects of patient care. Few academic cancer centers have been QOPI participants in the United States and there aren’t reports to our knowledge of any Latin American Cancer Center adopting this strategy. Methods: This study shows the pilot initiative to implement the QOPI at the ABC School of Medicine, Discipline of Oncology, a large public academic cancer center of Santo André, São Paulo, Brazil. Results: From January 2008 to December 2010, we consecutive selected 37 patients with gastric cancer, 40 with breast cancer, 33 with lung cancer and 40 colorectal cancer. The table below shows the first round of the core QOPI. Conclusions: There are several opportunities for improvement such as assessing and recording of pain and analgesic use, documentation patient consent and of the intent of chemotherapy and providing patients with their chemotherapy summaries. Our current electronic record will be modified to reflect the aforementioned needs in order to improve our results in the following rounds of QOPI program. [Table: see text]

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