Veliparib is a potent poly(ADP-ribose) polymerase inhibitor. This phase 1 study aimed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of veliparib combined with various FOLFIRI regimens in patients with solid tumours. Patients received veliparib (10–270 mg BID, days 1–5, 15–19) and FOLFIRI (days 1–3, 15–17) in three regimens containing 5-fluorouracil 2,400 mg/m2: irinotecan 150 mg/m2 and folinic acid 400 mg/m2 (part 1); irinotecan 180 mg/m2, folinic acid 400 mg/m2, and 5-fluorouracil 400 mg/m2 bolus (part 2), or irinotecan 180 mg/m2 (part 3). The RP2D was further evaluated in safety expansion cohorts. Preliminary antitumour activity was also assessed. Ninety-two patients received ≥1 veliparib dose. MTD was not reached; RP2D was set at 200 mg BID veliparib plus FOLFIRI (without 5-fluorouracil bolus). Most common treatment-emergent adverse events were neutropenia (66.3%), diarrhoea, and nausea (60.9% each). Dose-limiting toxicities (n = 4) were grade 3 gastritis and grade 4 neutropenia and febrile neutropenia. Veliparib exposure was dose-proportional, with no effects on the pharmacokinetics of FOLFIRI components. Fifteen patients had a partial response (objective response rate, 17.6%). The acceptable safety profile and preliminary antitumour activity of veliparib plus FOLFIRI support further evaluation of this combination.

/pdf/a-phase-1-dose-escalation-study-of-veliparib-with-bimonthly-118ozdx1xn.pdf

A phase 1 dose-escalation study of veliparib with bimonthly FOLFIRI in patients with advanced solid tumours.

Na konferencji ASTRO 56th Meeting w cześci poświeconej nowotworom dolnego odcinka przewodu pokarmowego prezentowane byly najnowsze doniesienia dotyczące raka odbytnicy i odbytu. Praktycznie brak nowych badan ściśle związanych z rakiem okreznicy, zarowno w wystąpieniach ustnych jak i plakatowych.Standardy leczenia raka odbytnicy nie ulegly zmianie, jednak zarysowują sie trendy:  deeskalacja leczenia chirurgicznego oraz propozycje modyfikacji – skracania czasu trwania leczenia neoadjuwantowego.

/pdf/ocena-najnowszych-trendow-w-diagnozowaniu-leczeniu-1hvlgfa8gs.pdf

Ocena najnowszych trendów w diagnozowaniu, leczeniu nowotworów złośliwych w lokalizacji dolnego odcinka przewodu pokarmowego na podstawie konferencji ASTRO’s 56th Annual Meeting

Rectal adenocarcinoma is an important cause of cancer-related deaths worldwide, and key anatomic differences between the rectum and the colon have significant implications for management of rectal cancer, especially in the curative setting. For stage II and III rectal cancers, combined chemoradiotherapy offers the lowest rates of local and distant relapse, and is delivered neoadjuvantly to improve tolerability and optimize surgical outcomes, particularly when sphincter-sparing surgery is an endpoint. We review both pivotal trial data that has shaped the current standard of care, fluoropyrimidine-based chemoradiotherapy, while also presenting results from more recent studies, which aim to outperform this standard. Strategies combining 5FU radiotherapy with oxaliplatin, VEGF inhibition, EGFR inhibition, other targeted agents, and/or use of induction chemotherapy hold promise but thus far have failed to improve outcomes in randomized trials. Results of studies such as the ongoing PROSPECT trial may help further define our current therapeutic algorithm for stage II and III rectal cancer.

The neoadjuvant treatment of rectal cancer: a review.

Combination of Novel Agents with Radiotherapy to Treat Rectal Cancer.

Personalized or precision medicine is an emerging treatment approach tailored to individuals or certain groups of patients based on their unique characteristics. These types of therapies guided by biomarkers tend to be more effective than traditional approaches, especially in cancer. The inhibitor against poly (ADP-ribose) polymerase (PARP), olaparib (Lynparza, AstraZeneca), which was approved by the US Food and Drug Administration (FDA) in 2014, demonstrated efficacy specifically for ovarian cancer patients harboring mutations in BRCA genes, which encode proteins in DNA double-strand break repairs. However, the response to PARP inhibitors has been less encouraging in other cancer types that also carry defects in the BRCA genes. Thus, furthering our understanding of the underlying mechanism of PARP inhibitors and resistance is critical to improve their efficacy. In this review, we summarize the results of preclinical studies and the clinical application of PARP inhibitors, and discuss the future direction of PARP inhibitors as a potential marker-guided personalized medicine for cancer treatment.

/pdf/parp-inhibitors-as-precision-medicine-for-cancer-treatment-4olobfpnnz.pdf

PARP inhibitors as precision medicine for cancer treatment

The Safety and Tolerability of Veliparib (V) plus Capecitabine (C) and Radiation (RT) in Subjects with Locally Advanced Rectal Cancer (LARC): Results of a Phase 1b Study

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The Safety and Tolerability of Veliparib (V) plus Capecitabine (C) and Radiation (RT) in Subjects with Locally Advanced Rectal Cancer (LARC): Results of a Phase 1b Study