Corrigendum to "Outcomes of Programmed Cell Death Protein 1 (PD-1) and Programmed Death-Ligand 1 (PD-L1) Inhibitor Therapy in HIV Patients with Advanced Cancer".

[This corrects the article DOI: 10.1155/2019/2989048.].

Outcomes of Programmed Cell Death Protein 1 (PD-1) and Programmed Death-Ligand 1(PD-L1) Inhibitor Therapy in HIV Patients with Advanced Cancer.

Due to HAART and consequent decline in mortality from infectious complications, HIV patients have an increasing burden of non-AIDS defining cancers. Data on their safety and efficacy is unknown as these patients were excluded from clinical trials due to concern of unforeseen side effects. Objectives. The main objective of our study was to evaluate the efficacy and safety profile of PD-1 and PD-L1 inhibitors in HIV patients being treated for advanced cancers and to assess the impact of these drugs on HIV status of the patients specifically CD4 count and HIV viral load. Materials and Methods. This was a retrospective analysis of data of 17 patients HIV treated with one of the PD-1/PD-L1 inhibitors (Nivolumab, Pembrolizumab, Atezolizumab, Durvalumab, or Avelumab) for advanced cancer. Results. 10 out of 17 patients responded to therapy. 7 patients, all of whom had shown response to therapy, were alive and 4 were still on checkpoint inhibitor. 10 patients including all 7 nonresponders had died. Responders had minimum of 15 weeks of response while one had ongoing continued response at 34 weeks. Side effects were seen in 7 patients and only one patient needed cessation of therapy. CD4 counts were stable on treatment while HIV RNA remained undetectable. Conclusion. PD-1 and PD-L1 inhibitors appear to have comparable efficacy and tolerable side effect profile and have no effect on HIV markers when used in HIV patients with advanced cancers.

Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study.

BACKGROUND: Previous phase 2 studies have shown antitumour activity with gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary-tract cancers (BTCs). In this phase 2 study, we assessed the efficacy and safety of combined bevacizumab with GEMOX (GEMOX-B) in patients with advanced BTCs, and investigated how changes in 18-fluorodeoxyglucose ([(18)F]FDG)-PET correlate with clinical outcome. METHODS: Patients with advanced measurable BTCs were given the following treatment on days 1 and 15 of a 28-day cycle: bevacizumab 10 mg/kg, followed by gemcitabine 1000 mg/m(2) (10 mg/m(2) per min) and oxaliplatin 85 mg/m(2) (2-h infusion). [(18)F]FDG-PET scans were obtained at baseline and after completion of the second cycle. The primary endpoint was progression-free survival (PFS). Efficacy and safety analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00361231. FINDINGS: 35 patients were enrolled and evaluable for efficacy and toxicity. Median PFS was 7.0 months (95% CI 5.3-10.3), and PFS at 6 months was 63% (47-79), which was below the targeted rate of 70%. Grade 3-4 toxic effects included neutropenia (n=7), raised alanine aminotransferase concentrations (n=5), peripheral neuropathy (n=5), and hypertension (n=5). [(18)F]FDG-PET scans showed a significant decrease in maximum standardised uptake value (SUV(max)) after two cycles of treatment (5.72 [SD 2.01] at baseline; 3.73 [SD 1.88] after two cycles; p<0.0001). These changes were more pronounced in patients with partial response or stable disease than those with progressive disease (24 patients, -2.80 [SD 1.95] vs five patients, 1.41 [SD 3.13]; p=0.009). Change in SUV(max) was a significant predictor of PFS (HR 1.35, 1.14-1.60, p=0.0006) and overall survival (1.25, 1.05-1.50, p=0.01). INTERPRETATION: GEMOX-B showed antitumour activity with tolerable safety in patients with advanced BTCs. Decreases in SUV(max) on [(18)F]FDG-PET scans after treatment were associated with disease control and increases in PFS and overall survival. FUNDING: Genentech Oncology and Sanofi-Aventis.

Sleep/Wake patterns of individuals with advanced cancer measured by ambulatory polysomnography.

PURPOSE: Sleep/wake disturbances are prevalent in patients with advanced cancer, but 24-hour polysomnography (PSG) examinations of these patterns have not been undertaken. The purpose of this study was to describe these sleep/wake patterns using continuous PSG and to explore relationships with selected demographic and clinical variables. PATIENTS AND METHODS: The sample included patients with advanced cancer (solid tumors); those with neurologic disorders or psychosis, substance abuse, or brain metastasis were excluded. The final sample included 114 participants with a mean age of 51.1 years (+/- 9.1 years). Participants underwent continuous, ambulatory PSG for 42 hours in their home environments. Standard PSG measures were calculated. Analysis included data from 2 nights and the intervening day. Descriptive statistics were used to summarize sleep/wake parameters of the average of the 2 nights and the intervening day. Nonparametric analyses were used to detect differences and relationships among the variables. RESULTS: Compared with normative data, participants had reduced quantity and quality of nocturnal sleep and episodes of sleep scattered throughout the day. Increased daytime sleep was negatively associated with several key parameters of nocturnal sleep quantity and quality. Women, whites, and those who were married/partnered and had more education had better nocturnal sleep. Cancer type and selected medications may be risk factors for disturbed sleep and waking. CONCLUSION: Participants experienced severe difficulty with "state maintenance", or the ability to maintain both the sleep and waking states. Research designed to identify the etiology of these problems is needed to develop effective interventions.

Novel agents and incremental advances in the treatment of head and neck cancer.

Cancer of the head and neck is an important medical problem, with approximately 46,500 cases predicted in the United States alone in 2003. Worldwide, more than 600,000 cases are anticipated. While several different histologic subtypes of head and neck cancer are seen in different parts of the world, more than 90% of tumors diagnosed in the United States are squamous cell carcinomas. Major strides in the management of this disease have been made in the last decade. These include, but are not limited to, the evolution of organ preservation, the increasingly well recognized role of concurrent chemoradiation therapy as either definitive therapy for unresectable disease or adjuvant therapy for high-risk surgical disease, and significant improvements in cytotoxic chemotherapy. The role of chemotherapy in this disease has been a subject of debate. Chemotherapy is now routinely included in the multimodality treatment of unresectable disease of the oral pharynx, larynx, and oral cavity. There is now increasing evidence supporting the role of induction chemotherapy in head and neck cancer. As intensified chemotherapy and radiation therapy have improved local control, the increasing incidence of distant metastases has necessitated the need for enhanced systemic control. These approaches are the topics of extensive investigations.