Randomized trial of sucrosomial iron supplementation in patients with chemotherapy-related anemia treated with ESA.

BACKGROUND: Iron supplementation improves the erythropoiesis-stimulating agents' (ESAs) response in chemotherapy-related anemia. The primary aim of our study is to assess the efficacy of sucrosomial iron, a new oral iron formulation, in cancer patients with chemotherapy-induced anemia treated with ESAs. The secondary objectives included the efficacy into two subgroups of patients (iron replete and functional iron deficiency) between the two study arms, safety and the effect on transfusion need. METHODS: In this randomized, multicentre, open-label, phase III clinical trial, 60 cancer patients were enrolled. Each patient was randomly assigned (1:1) to receive 12 weeks of oral sucrosomial iron at the dose of 30 mg daily in combination with ESAs or no supplementation to ESA treatment. The endpoint considered for efficacy was the proportion of patients achieving complete hematological response at 12 weeks (increase in Hb > 2 g/dL from baseline, without RBC transfusions in the previous 28 days or achieving Hb ≥ 12 g/dL). RESULTS: There was a statistically significant association between oral sucrosomial iron supplementation in combination with ESAs and the achievement of a complete hematological response. This response was achieved within 12 weeks by 31% of patients in the control group and by 52% of patients supplemented with oral sucrosomial iron. A trend of greater response in sucrosomial iron arm was found in both subgroups. No difference was observed about safety and transfusion need. CONCLUSIONS: Sucrosomial iron is well tolerated and its combination with ESAs improves the hematological response in cancer patients with chemotherapy-related anemia. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: This study has been reviewed by the Institutional Ethics Committee of the IRCCS Policlinico San Matteo Foundation, Pavia, Italy (28/04/2015; prot. N. 20,150,002,059), and by the Institutional Ethics Committee of the other Italian oncological centers involved in this study.

Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes.

PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer. METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness. RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC. CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540).

Can early palliative care with anticancer treatment improve overall survival and patient-related outcomes in advanced lung cancer patients? A review of the literature.

PURPOSE: Metastatic non-small-cell lung cancer (NSCLC), the leading cause of death from cancer worldwide, is a debilitating disease that results in a high burden of symptoms and poor quality of life; the estimated prognosis after the diagnosis has been established was less than 1 year until some years ago. At the present, the new targeted therapies and immunotherapy are changing the course of the disease. However, advanced NSCLC remains an incurable disease, with a poor prognosis for the majority of the affected patients, so that quality of life and relief from symptoms are primary objectives of treatment. Some evidences suggest that early palliative care (EPC) for these patients can improve quality of life and even survival. DESIGN: A systematic review of the studies evaluating the impact on objective and on patient-reported outcomes of the introduction of EPC in opposition to standard care (SC), for advanced lung cancer patients, was performed. Because of the small number of studies conducted in this area, retrospective studies were also considered for the review. RESULTS: Five studies were included because they matched the inclusion criteria previously defined as relevant for the study. The review found that both survival and quality of life were better for patients included in EPC groups. CONCLUSIONS: While results of the studies included in this review are not always comparable because different methods and scales have been used, there is enough evidence for clinical oncologists to implement the use of EPC in clinical practice for advanced lung cancer patients.

Prevalence study on potential drug-drug interaction in cancer patients in Piacenza hospital's Onco-Haematology department.

Background Cancer patients can be a human model of potential drug interactions. Usually they receive a large number of different medications, including antineoplastic agents, drugs for comorbid illness and medication for supportive care, however information about these interactions are fragmented and poor. Objective We assessed a prospective study to evaluate the prevalence of drug interaction among patients hospitalized in the Onco-Haematology department, Hospital of Piacenza. Methods Data on drugs administered for cancer, comorbidities, or supportive care were collected from different computerized prescription software in use in the department; we compared them with a database to focus on the co-administration of drugs. A literature review was performed to identify major potential drug interaction and to classify them by level of severity and by strengths of scientific evidence. Results In this study 284 cancer patients were enrolled; patients had taken an average of seven drugs on each day of therapy plus chemotherapeutic agents, we identified 67 potential drug interactions. At least 53 patients had one potential drug interaction. Of all potential drug interactions 63 were classified as moderate severity and only four as major. In 55 cases chemotherapeutic agents were involved in possible interactions with supportive care drugs, meanwhile in 12 cases the potential drug interactions were between supportive care drugs. Conclusions In our centre, thanks to a computerized prescription software, integrated with caution alarm in case of possible interaction, we had a lower rate of potential drug interactions than the one from literature. It is possible to improve the software integrating the alarm with the potential drug interactions between chemotherapy agents and supportive care drugs.

Intrapleural Trastuzumab Therapy for Malignant Pleural Effusion from HER2 Overexpression in Metastatic Gastric Cancer.

BACKGROUND: Malignant pleural effusion (MPE) is an extremely common problem affecting cancer patients with advanced disease. The current therapy for MPE is local treatment, such as thoracentesis, chemical pleurodesis, intracavitary administration of anticancer drugs and systemic therapy. However, the management of MPE is still unsatisfactory. CASE: We report a case of MPE secondary to human epidermal growth factor receptor 2 (HER2)-positive gastric cancer that was successfully treated with intrapleural trastuzumab. A 52-year-old male with metastatic HER2-positive gastric cancer received chemotherapy (FOLFOX4 regimen) plus trastuzumab; after 11 courses of chemotherapy, he developed right MPE refractory to systemic treatment and pleurodesis. A pleural biopsy performed during thoracoscopy showed pleural metastasis from HER2-positive gastric cancer. The patient received 2 courses of intrapleuric trastuzumab. After the second course, the MPE disappeared, and he continued systemic therapy with trastuzumab and docetaxel. CONCLUSION: The safety was good, no local or systemic complications occurred, and the dyspnea secondary to MPE improved and subsequently disappeared. To our knowledge, this case is the first report on intrapleuric trastuzumab use to treat refractory MPE secondary to metastasis from HER2-positive gastric cancer. The treatment was well-tolerated and efficacious.

Malignant pleural mesothelioma metastatic to the submandibular salivary gland, simulating glandular hypertrophy, diagnosed by fine-needle aspiration biopsy: a case report and literature review.

BACKGROUND: Malignant mesothelioma is a rare neoplasm that generally develops in the pleural or peritoneal cavity. Distant metastases are common; it rarely metastatizes to the head and neck region. CASE PRESENTATION: A 54-year-old white man, a non-smoker, was treated with chemotherapy, surgery and radiation for a malignant pleural mesothelioma. Seven months after the last treatment, he developed a right submandibular enlargement: clinical examination, ultrasound and computerized tomography scans revealed a salivary gland hypertrophy. Anti-inflammatory and antibiotic treatment was then started, without improvement. An ultrasound (US)-guided fine-needle aspiration biopsy (FNAB) showed atypical mesothelial cells with nuclear enlargement and increased chromatin representation. Immunocytochemistry showed positivity for calretinin and WT-1.A diagnosis of right submandibular salivary gland involvement from mesothelioma was established, allowing an adequate treatment. CONCLUSION: We report a very rare site of metastasis from malignant pleural mesothelioma. We suggest that US-guided FNAB is a useful, quick, and cheap procedure for a definite diagnosis.

FOLFIRINOX or Gemcitabine Plus Nab-paclitaxel as First Line Treatment in Pancreatic Cancer: A Real-World Comparison.

Background/Aim: Advanced pancreatic cancer has a poor prognosis and a 5-year survival rate <5%; thus, treatment of patients with advanced unresectable or metastatic disease is challenging. Current guidelines recommend either gemcitabine plus nab-paclitaxel (GnP) or FOLFIRINOX (FOL) as first-line treatment. Data on both efficacy and toxicity of FOL versus GnP in metastatic cancer are limited. This study aimed to compare the two chemotherapy regimens in terms of efficacy and toxicity in a real-world setting. Patients and Methods: This retrospective propensity score matching study reviewed the medical records of 123 consecutive patients with advanced or metastatic pancreatic cancer who received either GnP or FOL between March 2013 and January 2019 in Guglielmo da Saliceto Hospital, Piacenza. Results: Fifty patients (40.65%) received FOL, administered in an attenuated dose, and seventy-three patients (59.35%) received GnP. After a propensity matching score, 100 patients were retrospectively evaluated. In the final matched cohort, there was no difference in neoadjuvant therapy, radiotherapy, and surgery performed before the first-line therapy between the two groups. Progression-free survival and overall survival were comparable between the two groups and no difference was found in the percentage of toxicity. Conclusion: There was no difference in outcomes between patients who received FOL and those who received GnP. Unexpectedly, no greater FOL-related toxicity was found, probably due to the dose reduction.

Emerging Therapeutic Targets and Future Directions in Advanced Gastric Cancer: A Comprehensive Review.

Metastatic gastric cancer (GC) still represents a critical clinical challenge, with limited treatment options and a poor prognosis. Most patients are diagnosed at advanced stages, limiting the chances of surgery and cure. The identification of molecular targets and the possibility of combining immune checkpoint inhibitors with chemotherapy have recently reshaped the therapeutic landscape of metastatic gastric cancer. The new classification of gastric cancer, mainly based on immunologic and molecular criteria such as programmed cell death 1 (PD-1), microsatellite instability (MSI), and human epidermal growth factor receptor 2 (HER2), has made it possible to identify and differentiate patients who may benefit from immunotherapy, targeted therapy, or chemotherapy alone. All relevant and available molecular and immunological targets in clinical practice for the systemic treatment of this disease are presented. Particular attention is given to possible future approaches, including circulating tumor DNA (ctDNA) for therapeutic monitoring, new targeting agents against molecular pathways such as fibroblast growth factor receptor (FGFR) and MET, chimeric antigen receptor (CAR)-T cells, and cancer vaccines. This review aims to provide a comprehensive understanding of current targets in advanced gastric cancer and to offer valuable insights into future directions of research and clinical practice in this challenging disease.

Unraveling the Interplay of KRAS, NRAS, BRAF, and Micro-Satellite Instability in Non-Metastatic Colon Cancer: A Systematic Review.

Microsatellite Instability (MSI-H) occurs in approximately 15% of non-metastatic colon cancers, influencing patient outcomes positively compared to microsatellite stable (MSS) cancers. This systematic review focuses on the prognostic significance of KRAS, NRAS, and BRAF mutations within MSI-H colon cancer. Through comprehensive searches in databases like MEDLINE, EMBASE, and others until 1 January 2024, we selected 8 pertinent studies from an initial pool of 1918. These studies, encompassing nine trials and five observational studies involving 13,273 patients, provided insights into disease-free survival (DFS), survival after recurrence, and overall survival. The pooled data suggest that while KRAS and BRAF mutations typically predict poorer outcomes in MSS colorectal cancer, their impact is less pronounced in MSI contexts, with implications varying across different stages of cancer and treatment responses. In particular, adverse effects of these mutations manifest significantly upon recurrence rather than affecting immediate DFS. Our findings confirm the complex interplay between genetic mutations and MSI status, emphasizing the nuanced role of MSI in modifying the prognostic implications of KRAS, NRAS, and BRAF mutations in colon cancer. This review underscores the importance of considering MSI alongside mutational status in the clinical decision-making process, aiming to tailor therapeutic strategies more effectively for colon cancer patients.

Exploring the Horizon: Anti-Fibroblast Growth Factor Receptor Therapy in Pancreatic Cancer with Aberrant Fibroblast Growth Factor Receptor Expression-A Scoping Review.

Pancreatic cancer is a highly lethal disease, often diagnosed at advanced stages, with a 5-year overall survival rate of around 10%. Current treatments have limited effectiveness, underscoring the need for new therapeutic options. This scoping review aims to identify and summarize preclinical and clinical studies on FGFR (Fibroblast Growth Factor Receptor) inhibitors, including tyrosine kinase inhibitors (TKIs) and FGFR-specific inhibitors, in pancreatic cancer with FGFR alterations. We included studies analyzing efficacy, safety, and survival outcomes in various populations. A comprehensive search across major databases identified 73 relevant studies: 32 preclinical, 16 clinical, and 25 from gray literature. The clinical trials focused primarily on efficacy (20 studies) and safety (14 studies), with fewer studies addressing survival outcomes. FGFR1 was the most studied alteration, followed by FGFR2 and FGFR4. Although FGFR alterations are relatively rare in pancreatic cancer, the available data, including promising real-life outcomes, suggest significant potential for FGFR inhibitors. However, more extensive research is needed to identify the correct genetic drivers and gather robust survival data. Ongoing and future trials are expected to provide more comprehensive insights, potentially leading to improved targeted therapies for pancreatic cancer patients with FGFR alterations.

Evolving approaches in advanced gallbladder cancer with complete pathological response using chemo­immunotherapy: A case report.

The combination of chemotherapy and immunotherapy for metastatic cholangiocarcinoma (CCA) offers promising improvements in survival and response rates beyond traditional treatments. TOPAZ-1 and KEYNOTE-966 have demonstrated the efficacy of combining immunotherapy (durvalumab and pembrolizumab) with chemotherapy, even in gallbladder cancer (GBC), with a complete response rate of 2.7% in the TOPAZ-1 trial. Advanced CCA treated with immunotherapy combinations has shown complete responses influenced by high programmed death-ligand 1 (PD-L1) or Epstein-Barr virus expression. These responses were enhanced by combining radiotherapy with programmed cell death protein 1 (PD-1) blockade. A 62-year-old man was diagnosed with unresectable GBC, distant lymphatic metastases, and local invasion of liver segments 4i and 5, the colonic hepatic flexure, the duodenal bulb, and the pancreatic head. Immunohistochemical examination revealed poorly differentiated squamous cell carcinoma, without expression of PD-L1. Next generation sequencing revealed the mutation of ERBB2 R678Q and a microsatellite stable tumour. The patient started chemo-immunotherapy with cisplatin-gemcitabine plus durvalumab in June 2022. After eight cycles, a significant reduction in tumour volume and markers was reported, and therapy with durvalumab was maintained through November 2023. The subsequent computed tomography scans showed further reduction in the tumour volume, and surgical resection was performed. Histological examinations confirmed the absence of residual tumour or lymph node metastases. As of June 2024, the patient has shown no signs of disease recurrence. Several reports of conversion surgery in GBC exist, but data on pre-surgical chemo-immunotherapy are limited. Furthermore, a complete response without pathological confirmation in CCA and GBC raises several questions regarding the need for surgery after immunotherapy. Although effective disease control and tumour regression have been reported in advanced GBC with combined anti-cytotoxic T-lymphocyte associated protein 4 and anti-PD-1 agents and chemotherapy, further studies are needed to identify reliable predictive biomarkers due to unclear associations with PD-L1 expression or tumour mutational burden. Overall, chemo-immunotherapy has been effective in treating metastatic CCA, especially when tailored to specific molecular profiles. These treatments may lead to complete responses and novel strategies.

Targeting FGFR Pathways in Gastrointestinal Cancers: New Frontiers of Treatment.

In carcinogenesis of the gastrointestinal (GI) tract, the deregulation of fibroblast growth factor receptor (FGFR) signaling plays a critical role. The aberrant activity of this pathway is described in approximately 10% of gastric cancers and its frequency increases in intrahepatic cholangiocarcinomas (iCCAs), with an estimated frequency of 10-16%. Several selective FGFR inhibitors have been developed in the last few years with promising results. For example, targeting the FGFR pathway is now a fundamental part of clinical practice when treating iCCA and many clinical trials are ongoing to test the safety and efficacy of anti-FGFR agents in gastric, colon and pancreatic cancer, with variable results. However, the response rates of anti-FGFR drugs are modest and resistances emerge rapidly, limiting their efficacy and causing disease progression. In this review, we aim to explore the landscape of anti-FGFR inhibitors in relation to GI cancer, with particular focus on selective FGFR inhibitors and drug combinations that may lead to overcoming resistance mechanisms and drug-induced toxicities.

Prognostic Impact of Ras Mutation on Surgical Strategy in Rectal Cancer Patients Undergoing Neoadjuvant Treatment.

BACKGROUND/AIM: Complete clinical response in rectal cancer after neoadjuvant chemo-radiotherapy is challenging. Indeed, indication to surgery vs. "watch and wait" is a debate due the poor predictive value of restaging exams in order to identify a pathological complete response (pCR). Improving the knowledge on mutational pathways such as MAPK/ERK could be helpful in assessing the real impact of disease on prognosis and in choosing the best therapeutic target. This study aimed to evaluate the significance of biomolecular parameters as prognostic factors in patients undergoing radical surgery after chemo-radiotherapy. PATIENTS AND METHODS: A retrospective analysis was performed including 39 patients who had undergone radical surgery after neoadjuvant chemo-radiotherapy for rectal adenocarcinoma stage II-III through additional evaluation of the following biomolecular markers on surgical specimens: exons 2, 3 and 4 of the KRAS and NRAS genes and exon 15 of BRAF by pyrosequencing. Kaplan-Meier survival curves were plotted to evaluate the association of pathologic response and RAS status with progression-free survival (PFS) and overall survival (OS). The log-rank test was used to assess statistical differences among the survival curves. RESULTS: Data analysis showed RAS mutation in 15 patients (38.46%). pCR was achieved in seven patients (18%), including only two RAS mutation cases. The distribution of evaluated variables was homogeneous in the two groups based on pathological response. The Kaplan-Meier curve showed poor outcomes in OS and PFS in patients with RAS mutation (p=0.0022 and p=0.000392, respectively), but no significant differences based on pathological response for both OS and PFS. CONCLUSION: RAS mutation seems to be related to poor prognosis and increased risk of recurrence in rectal cancer patients undergoing radical surgery after chemo-radiotherapy.

Feasibility and Utility of Incorporating Patient-Reported Outcomes into Surveillance Strategies for Advanced Lung Cancer.

PURPOSE: To identify and to describe patient-reported outcomes (PROs) in lung cancer patients and to evaluate the feasibility and utility of PROs into surveillance strategies, a review was carried out. PATIENTS AND METHODS: A systematic search in bibliographic databases evaluating the instruments used in PROs of non-small-Cell lung cancer (NSCLC) patients was done. RESULTS: From August 2014 to August 2019, 33 studies were included in this review and 16,491 patients were evaluated. PROs were divided into 6 different categories: 1) PROs as a guide in therapeutic choice, 2) PROs as indicator of disease progression, 3) agreement between PROs and the evaluated parameters, 4) PROs to evaluate the effects of immunotherapy, 5) need to deepen the knowledge of PROs, and 6) use of new electronic PROs. CONCLUSION: The most frequently used instruments are EORTC QLQ-30 (16, 50%) and EORTC LC-13 (14, 43.75%) and in some studies (37.5%) they are used together. For different reasons (disease progression, adverse event, death, incomplete participation, etc.), the completion of these instruments decreased over time from baseline to subsequent measurements. This review demonstrates that PROs can play an important role as part of health care, and that routine use implementation could improve patient management in addition to the traditionally collected outcome.

Central venous catheterization in cancer patients with severe thrombocytopenia: Ultrasound-guide improves safety avoiding prophylactic platelet transfusion.

Prior research has revealed that ultrasound (US) guided central venous catheterization (CVC) is associated with a reduction in the complication rate such as pneumothorax and an improved first-pass success placing CVC in the internal jugular vein. The present study investigated if US-guided CVC, in a subset of cancer patients with severe thrombocytopenia, reduced bleeding risk and avoided prophylactic platelet transfusion. The efficacy and safety of US-guided CVC placement in cancer patients with severe thrombocytopenia was retrospectively analyzed over a period of 9 years (Dec 2000-Jan 2009), 1,660 and 207 patients with cancer underwent US-guided CVC placement into internal jugular vein respectively at the Department of Onco-Haematology, Hospital of Piacenza. The first group of patients included patients in active antitumor treatment, while the second group included patients in the palliative phase. A total of 110 (5.89%) of these 1,867 patients exhibited severe thrombocytopenia defined as platelet count ≤20x109/l, and formed the basis of this study. All procedures were evaluated for bleeding complications as defined by the National Institute of Health Common Terminology Criteria for Adverse Events (CTCAE 3.0). In the subgroup of the 110 patients with severe thrombocytopenia a single needle puncture of the vein was employed in 121 of the 122 procedures (99.18%) and no attempt failures were registered. No pneumothorax, no major bleeding and no nerve and arterial puncture were reported, only one self-limiting hematoma (0.90%) at the site of CVC insertion was reported (CTCAE 3.0 grade 1). No platelet transfusions were performed in the 110 patients, pre and post CVC placement. We believe that US-guided CVC insertion procedures into the internal jugular vein makes the difference in safety, also in thrombocytopenic patients avoiding prophylactic or post procedure platelet transfusion.

Immune checkpoint inhibitors in EGFR-mutation positive TKI-treated patients with advanced non-small-cell lung cancer network meta-analysis.

Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) mutation benefit from a first line of treatment with tyrosine kinase inhibitors (TKIs). After progression, the choice of treatment is between chemotherapy and immune checkpoint inhibitors, but the role of EGFR mutation in the response to immunotherapy is still unclear. A network meta-analysis was performed and 4 randomized trials comparing immune checkpoint inhibitors versus chemotherapy were identified. A Bayesian network meta-analysis was carried out to compare three checkpoint inhibitors (nivolumab, pembrolizumab and atezolizumab) versus chemotherapy (docetaxel), evaluating their Hazard Ratio (HR) and 95% Confidence Interval (CI) for Overall Survival (OS). Results suggest that patients with NSCLC and EGFR mutation, previously treated with TKIs, show better OS when treated with docetaxel in comparison to checkpoint inhibitors treatment.

Modified FOLFIRINOX for unresectable locally advanced/metastatic pancreatic cancer. A real-world comparison of an attenuated with a full dose in a single center experience.

Purpose: Metastatic pancreatic adenocarcinoma has a very poor prognosis. Although irinotecan, oxaliplatin and leucovorin-modulated fluorouracil (FOLFIRINOX) significantly increases survival in advanced pancreatic cancer, compared to employing only gemcitabine (GEM), toxicities have tempered enthusiasm for its use. Methods: This study retrospectively analyses the real-world clinical practice with full and attenuated doses of FOLFIRINOX in unselected patients with locally advanced unresectable or metastatic pancreatic cancer, treated at an Italian general hospital. Efficacy, tolerability, and toxicity were evaluated, and overall survival (OS) and progression-free survival (PFS) were estimated by Kaplan-Meier method. Results: Fifty consecutive patients with advanced (13) or metastatic (37) pancreatic adenocarcinomas were treated with FOLFIRINOX at the Medical Oncology Unit, Piacenza General Hospital, North Italy. The first enrolled consecutive 18 patients (36%) of this series started the treatment with a full dose of the regimen, while the subsequent 32 (64%) consecutive patients received dose attenuation (-20% bolus fluorouracil and -25% irinotecan). In the entire group, the response rate, median OS, and median PFS were 30%, 10.1 months, and 5.6 months, respectively, with no differences in objective response in the 32 patients that received an attenuated dose compared with the 18 patients receiving a full dose of chemotherapy. However, neutropenia, anemia, fatigue, and vomiting were statistically increased in the 18 patients receiving a full dose compared with the 32 patients receiving an attenuated dose of FOLFIRINOX (p<0.05). Conclusion: This study demonstrates the efficacy and tolerability of modified FOLFIRINOX in advanced and metastatic pancreatic cancer.

Second-line chemotherapy for the treatment of metastatic pancreatic cancer after first-line gemcitabine-based chemotherapy: a network meta-analysis.

Guidelines for treatment of metastatic pancreatic cancer recommend a second line based on Fluoropyrimidine (FP) alone or in combination with Oxaliplatin (OXA) or Irinotecan (IRI) after a first line treatment based on Gemcitabine (GEM). We conducted a Bayesian network meta-analysis to compare currently available therapies to treat metastatic pancreatic cancer in the second line, considering as efficacy measures overall survival (OS) and progression free survival (PFS). Published randomized trials were identified using electronic databases (MEDLINE, PubMed, https://clinicaltrials.gov/ and American Society of clinical oncology). 8 studies met the inclusion criteria for a total of 1,587 patients and 7 different therapeutic schemes. The results suggested that the use of IRI-FP-Folinic Acid scheme in the second-line treatment of metastatic pancreatic cancer may offer a benefit in terms of OS and PFS for patients not previously treated with these drugs.

Thoracentesis in advanced cancer patients with severe thrombocytopenia: Ultrasound guide improves safety and reduces bleeding risk.

BACKGROUND: Patients with severe thrombocytopenia are considered at risk for bleeding during invasive procedures as thoracentesis. The use of ultrasound (US) significantly reduces the rate of pneumothorax from thoracentesis, but there is a lack of data on safety and efficacy of US guidance in reducing bleeding complications in thoracentesis performed on patients with severe thrombocytopenia. METHODS: We retrospectively analysed the efficacy and safety of thoracentesis in cancer patients with severe thrombocytopenia. From January 2005 to December 2011, 462 patients underwent thoracentesis. Procedures were divided into 2 groups: performed without or with US guidance. All procedures were evaluated for bleeding complications as defined by the National Institutes of Health Common Terminology Criteria for Adverse Events. RESULTS: A total of 436 consecutive evaluable thoracentesis were analysed. Thoracentesis was performed with US guidance in 310 cases. Forty-one patients (9.40%) had severe thrombocytopenia. In 32 of these 41 patients, thoracentesis was performed under US guidance while in 9 cases the procedure was performed without US guidance. Three mild haemorrhagic complications (0.69% of the procedures performed) were observed and all occurred in group of the 9 (33.33%) patients with severe thrombocytopenia who underwent thoracentesis without US guidance. No haemorrhagic complications were recorded in the 427 patients, including the 32 patients with severe thrombocytopenia, in whom thoracentesis was performed with US guidance. CONCLUSIONS: US guided thoracentesis is a safe and effective approach in cancer patients with severe thrombocytopenia. Our results indicate that this procedure, when US-guided, can be safety performed even in patients with platelet count below 30 × 109 /L.