Cetuximab and anemia prevention in head and neck cancer patients undergoing radiotherapy.

BACKGROUND: Epidermal growth factor receptor (EGFR) activation is associated with increased production of interleukin 6 (IL6), which is intensified by radiotherapy (RT) induced inflammatory response. Elevated IL6 levels intensifies RT-induced anemia by upregulating hepcidin causing functional iron deficiency. Cetuximab, an EGFR inhibitor, has been associated with lower rates of anemia for locally advanced head and neck squamous cell carcinoma (HNSCC). We hypothesized that concomitant cetuximab could prevent RT-induced anemia. METHODS: We queried our institutional head and neck cancers database for non-metastatic HNSCC cases that received RT with concomitant cetuximab or RT-only between 2006 and 2018. Cetuximab was administered for some high-risk cases medically unfit for platinum agents per multidisciplinary team evaluation. We only included patients who had at least one complete blood count in the 4 months preceding and after RT. We compared the prevalence of anemia (defined as hemoglobin (Hb) below 12 g/dL in females and 13 g/dL in males) and mean Hb levels at baseline and after RT. Improvement of anemia/Hb (resolution of baseline anemia and/or an increase of baseline Hb ≥1 g/dL after RT), and overall survival (OS) in relation to anemia/Hb dynamics were also compared. RESULTS: A total of 171 patients were identified equally distributed between cetuximab-plus-RT and RT-only groups. The cetuximab-plus-RT group had more locally-advanced stage, oropharyngeal and high grade tumors (p < 0.001 for all). Baseline anemia/Hb were similar, however anemia after RT conclusion was higher in the cetuximab-plus-RT vs RT-only (63.5% vs. 44.2%; p = 0.017), with a mean Hb of 11.98 g/dL vs. 12.9 g/dL; p = 0.003, for both respectively. This contributed to significantly worse anemia/Hb improvement for cetuximab-plus-RT (18.8% vs. 37.2%; p = 0.007). This effect was maintained after adjusting for other factors in multivariate analysis. The prevalence of iron, vitamin-B12 and folate deficiencies; and chronic kidney disease, was non-different. Baseline anemia was associated with worse OS (p = 0.0052) for the whole study cohort. Nevertheless, improvement of anemia/Hb was only marginally associated with better OS (p = 0.068). CONCLUSIONS: In contrast to previous studies, cetuximab was not associated with lower rates of anemia after RT for nonmetastatic HNSCC patients compared to RT-alone. Dedicated prospective studies are needed to elucidate the effect of cetuximab on RT-induced anemia.

Rapid colonoscopy preparation using bolus lukewarm saline combined with sequential posture changes: a randomized controlled trial.

OBJECTIVE: In this randomized clinical trial, we have compared the Shudh™ colon cleanse (SCC) with HalfLytely(®) colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability. METHODS: Patients were randomized to receive either SCC (n = 65) or HCP (n = 68). All colonoscopies were performed by a single, blinded endoscopist. Colon prep was evaluated on a 5 point grading scale. Statistical non-inferiority was pre-defined as a difference of <15 % in the lower limit of the 95.5 % confidence interval for the treatment difference. Data that were collected include bowel prep score, BPT, adverse events, electrolyte abnormalities and patient acceptability. RESULTS: Bowel preparation efficacy was rated as "successful" for 59/65 (90.7 %) in SCC versus 66/68 (97.1 %) in HCP. This gave a success difference of -6.4 % with a 1-sided 95 % lower confidence limit (LCI) for the difference = -13.3 % (non-inferiority p = 0.25). This difference fell within the predefined limit for non-inferiority. The average BPT for SCC was 1.9 h versus 10.9 in HCP (p < 0.001). No serious adverse events were reported in either group. None of the patients in either group had any clinically significant electrolyte imbalance. Patient ratings for palatability and willingness to repeat were significantly better for SCC (p < 0.05). CONCLUSION: SCC was found to not be inferior to PEG with regards to the quality of bowel preparation. It is worth highlighting that a major advantage of SCC is shorter BPT.

Efficacy of bolus lukewarm saline and yoga postures as colonoscopy preparation: a pilot study.

BACKGROUND: Colonoscopy is now the gold standard for colon cancer screening and a vital diagnostic and therapeutic tool in 21st century medical practice. Although advances have been swift since colonoscopy came into wide use a generation ago, its effectiveness can be compromised by patients' ability to adequately prepare for the procedure. Many patients dread this task more than the procedure itself. While no prep regimen can be ideal for all patients, the authors present a novel approach that represents a potential time-saving improvement for younger, healthier patients. It is a modern version of an Indian practice called shankh prakshalana, in which lukewarm saline is used in combination with five yoga postures to cleanse the bowel. OBJECTIVE: The objective of this study was to examine the safety, efficacy, and tolerability of lukewarm saline and yoga (LWS/yoga) as a colonoscopy preparation in comparison with NuLytely(®) (PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride solution) used according to the manufacturer's instructions. RESEARCH DESIGN: This was a pilot study comprising 54 healthy adults, ages 18-65, equally divided into two groups: Group A preparing with lukewarm saline and yoga postures (LWS/yoga); and Group B preparing with NuLytely(®) as directed on the label. MEASUREMENTS: Data were collected on the quality of bowel preparation, patient safety, patient tolerability, and side-effects. The setting was a Joint Commission accredited outpatient endoscopy clinic. INTERVENTIONS: Patients performed the series of five yoga postures known as shankh prakshalana, interrupting the exercises at regular intervals to consume 480 mL of lukewarm saline. The solution was prepared by adding 9 g of sodium chloride per liter of lukewarm water (99°F-102°F/37.2°C-38.9°C). RESULTS: The mean total score was significantly better in Group A versus Group B (20.63 ± 5.09 versus 16.48 ± 5.18, p < 0.0007). In Group A, 24/27 (88.9%) of patients had excellent or optimum total scores, compared with 21/27 (77.8%) in Group B (not significant). In our pilot study, LWS/yoga, used under supervision, produced better colon preparation than Nulytely, used as directed. LIMITATIONS: A randomized, endoscopist-blinded study is needed to confirm these results. CONCLUSIONS: Shankh prakshalana is effective as a colonoscopy preparation.