Phase II Study of Panitumumab Monotherapy in Chemotherapy‐Naïve Frail or Elderly Patients with Unresectable RAS Wild‐Type Colorectal Cancer: OGSG 1602

Lessons Learned

• Panitumumab monotherapy showed favorable efficacy and feasibility in the treatment of frail or elderly patients with RAS wild‐type unresectable colorectal cancer.
• It is especially effective for left‐sided tumors; therefore, panitumumab as first‐line treatment could be an additional therapeutic option for frail elderly patients, particularly in those who are unsuitable for upfront oxaliplatin‐based or irinotecan‐based combination regimens.

BackgroundFirst‐line panitumumab monotherapy is expected to be well tolerated and improve survival in patients ineligible for intensive chemotherapy. However, its safety and efficacy in chemotherapy‐naïve frail or elderly patients with unresectable RAS wild‐type (WT) colorectal cancer (CRC) have not been studied. The aim of this phase II trial was to evaluate the efficacy and safety of panitumumab as first‐line treatment.MethodsWe conducted a multicenter phase II study on patients aged ≥76 years or ≥65 years considered unsuitable for intensive chemotherapy. Panitumumab 6 mg/kg of intravenous infusion was administered every 2 weeks. The primary endpoint was disease control rate (DCR). Secondary endpoints included progression‐free survival (PFS), overall survival (OS), response rate (RR), time to treatment failure (TTF), and incidence of grade 3 or 4 toxicities.ResultsThirty‐six patients (median age: 81 [range, 67–88] years) were enrolled between February 2017 and August 2018. Two patients were excluded from the analysis of efficacy: one from lack of image examination at baseline and the other from lack of a measurable lesion. Thirty‐three (91.6%) patients had a performance status (PS) of 0 or 1, whereas two (5.6%) patients and one (2.8%) patient had a PS of 2 and 3, respectively. Twenty‐eight patients (77.8%) had left‐sided CRC, whereas eight (22.2%) had right‐sided CRC. The RR was 50.0% (95% confidence interval [CI], 32.4–67.6), including three patients (8.8%) who had complete responses. A total of 26.5% had stable diseases, resulting in a DCR of 76.5% (90% CI, 61.5–87.7). The RR of patients with left‐ and right‐sided tumors was 65.4% (95% CI, 44.3–82.8) and 0.0% (95% CI, 0.0–36.9), respectively. Major grade 3 or 4 nonhematologic toxicities were rash (n = 6, 16.7%), hypomagnesemia (n = 4, 11.1%), fatigue (n = 3, 8.3%), paronychia (n = 2, 5.6%), and hyponatremia (n = 2, 5.6%). The only grade 3 hematologic toxicity was neutropenia (n = 1, 2.8%).ConclusionPanitumumab monotherapy showed favorable efficacy and feasibility in frail or elderly patients with RAS WT unresectable CRC. Survival analysis including OS, PFS, and TTF is currently in progress.     

Hypertension artérielle du sujet âgé en France : caractéristiques du traitement et fréquence de la plainte cognitive selon l’enquête FLAHS 2014

ObjectiveDescribe hypertensive patients treated in 2014 in France by age and estimate the degree of cognitive complaint among subjects aged 55 and over.MethodFrench League against Hypertension Survey (FLAHS) was conducted by mail in a representative sample of subjects aged 35 and over living in metropolitan France. Antihypertensive treatment data were obtained by self-administered questionnaire. Among the owners of a self-measurement device, blood pressure was considered to be controlled if the average of three measurements in the morning was below 135/85 mmHg. Cognitive complaint was detected by the cognitive complaint questionnaire (QPC) and analyzed by age and medical history of each subject.ResultsIn 2014, 30% of the population aged 35 and over (11.6 million) was treated with antihypertensive drugs. The number of treated hypertensive was: 3.45 million in the 75 and older, 2.96 million in 65–74 years, 3.24 million in 55–64 years, 1.58 million in the 45–54 years and 0.441 million in 35–44. The mono/bi/tri/quad-therapy is used in 46%/35%/14%/5% of patients. This distribution varies with age with monotherapy used in 63% of subjects under 55 years but in 40% of subjects 75 years and over. A positive QPC was noted in 11% of 55–64 years, in 21% of 75 years and older (P < 0.001), in 20% of uncontrolled hypertensive patients, and in 34% of subjects with a personal history of stroke.ConclusionIn France, hypertension is a disease that affects mainly the elderly. The modalities of treatment are different depending on age. Cognitive complaints are more common in uncontrolled hypertensive patients and in patients with a history of stroke.