Hepatic arterial infusion (HAI) and systemic chemotherapy for unresectable liver metastases (LM) from colorectal carcinoma (CC)

Median survival of untreated patients with LM from CC ranges from 3 to 12 months (m) after diagnosis. Better results were seen with HAI, also in association with systemic chemotherapy (JNCI; 88:252-8 1996). We treated 26 patients (20 men, 6 women; mean age 58 yr) with LM (18 synchronous and 8 metachronous; 20 pts had more than 3 lesions). Two different dose-schedules were administered: (1) 5-fluorouracil (5-FU) 200 mg/m2/day iv chronic continuous infusion (cci) and HAI with cyclophosphamide (CTX) 250 mg/m2 plus platin (P) 25 mg/m2 for 3 consecutive days every 3 weeks (10 pts); (2) 5-FU 300 mg/m2/day (cci) and CTX 330 mg/m2 plus P 33 mg/m2 with the same schedule as above (16 pts). 23 pts were chemo-naive, while 3 pts were pre-treated with 5 FU-based regimen. At a median follow up of 18 m, 18 pts were alive and 8 have died. Response (WHO criteria): on 22 evaluable pts (4 too early) 3 complete response (CR, 14%), 7 partial response (PR, 32%), 6 disease stabilization (SD, 27%) and 6 disease progression (PD, 27%) for an overall response rate of 46%. Median duration of response was 14 m (range 3 to 29+). The actuarial overall survival at 3 years was 35%. As regards the different chemotherapy dosages, better results were seen in patients who received the higher doses of drugs, with a response rate of 58% (vs 30%) and a median duration of response of 19 m (vs 11). Grade 3-4 toxicity (26 pts evaluable) was seen in 8 pts (31%), mostly hematological and mucosal, with one toxic death for severe enteritis. In conclusion, combined locoregional and systemic chemotherapy is active in unresectable LM from CC. The study is ongoing also with G-CSF rescue

Vasomotor symptoms and management of women undergoing treatment for breast cancer: literature review with focus on the therapeutic potential of cytoplasmic pollen extract

Objective Effective management of vasomotor symptoms (VMS) in patients undergoing treatment for breast cancer (BC) represents a critical but frequent unmet need. This review summarizes the epidemiology, pathophysiology, and clinical features of VMS in patients with BC and provides a synopsis of the complementary and alternative medicine (CAM) approaches in relieving VMS with a focus on purified cytoplasm of pollen (PCP).Methods The literature on VMS epidemiology, pathophysiology, clinical burden, and CAM treatment in healthy women and patients with BC was reviewed.Results VMS are common in patients with BC undergoing hormonal treatment and negatively impact quality of life, leading to treatment discontinuation in up to 25% of patients with detrimental impact on risk of BC recurrence and overall survival. CAM approaches to treat VMS in patients with BC include vitamin E, phytoestrogens, and black cohosh, even if there is a lack of solid evidence to guide clinicians in the choice of treatment. PCP, obtained according to standards of good manufacturing practice, has a definite pharmacological mechanism of action, is devoid of estrogen activity, and has shown clinical efficacy on menopause-associated symptoms with a favorable safety profile and high compliance. As such, it appears to represent a valid management option to improve quality of life in patients with pre- and postmenopausal BC.Conclusions Physicians should actively investigate the presence and impact of VMS in patients receiving therapy for BC. Additional and appropriately sized randomized clinical trials are needed to provide clear evidence on how to best meet the needs of patients with BC suffering from menopause-associated symptoms

Prognostic analysis and outcomes of metastatic pancreatic cancer patients receiving nab‐paclitaxel plus gemcitabine as second or later‐line treatment

Abstract Background Pancreatic cancer (PC) first‐line therapy often consists of polychemotherapy regimens, but choosing a second‐line therapy after disease progression, especially following first‐line FOLFIRINOX, remains a clinical challenge. This study presents results from a large, multicenter, retrospective analysis of Italian patients with metastatic PC (mPC) treated with Nab‐paclitaxel/Gemcitabine (AG) as second or later line of treatment. Main objective of the study is to identify prognostic factors that could inform treatment decisions. Methods The study included 160 mPC patients treated with AG in 17 Italian institutions. AG was administered according to labelling dose, until disease progression, unacceptable toxicity or patient refusal. Variations in schedules, dose modifications, supportive measures, and response evaluation were determined by individual clinicians' practice. Results AG was well‐tolerated and exhibited promising clinical activity. The overall response rate (ORR) and the disease control rate (DCR) were 22.5% and 45.6%, respectively. Median progression‐free survival (PFS) and overall survival (OS) were 3.9 and 6.8 months, respectively. Among the patients who received AG as a second‐line therapy (n = 111, 66.9%), median PFS and OS were 4.2 and 7.4 months, respectively. Notably, in the 76 patients (68%) receiving AG after first‐line FOLFIRINOX, an ORR of 19.7% and a DCR of 46.0% were observed, resulting in a median PFS of 3.5 and median OS of 5.7 months. The study identified specific clinical or laboratory parameters (LDH, NLR, fasting serum glucose, liver metastases, ECOG PS, and first‐line PFS) as independent prognostic factors at multivariate level. These factors were used to create a prognostic nomogram that divided patients into three risk classes, helping to predict second‐line OS and PFS. Conclusions This study represents the largest real‐world population of mPC patients treated with AG as a second or later line of therapy. It supports the feasibility of this regimen following first‐line FOLFIRINOX, particularly in patients with specific clinical and laboratory characteristics who derived prolonged benefit from first‐line therapy