Development and Validation of a New Evaluation Index for Oxaliplatin-Induced Cold Hypersensitivity Symptoms | Abstract
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Development and Validation of a New Evaluation Index for Oxaliplatin-Induced Cold Hypersensitivity Symptoms

Author(s): Ryu Hashimoto*, Junya Sato, Hiroshi Ishiguro, Natsuko Sugiyama, Takeshi Ito, Yoshinori Kato, Keiji Kuramoto, Kayoko Maezawa, Yasuyuki Momose

Purpose: Peripheral neuropathy (PN) is a dose limiting factor and reduces the quality of life. However, many studies have not provided a distinction between cold hypersensitivity symptoms (CHS) and chronic neuropathy. We developed a new evaluation index for CHS and examined its efficacy.

Method: The subjects were patients who received mFOLFOX6 therapy ± molecular target drug for colorectal cancer. The new evaluation index (Cold-Hypersensitivity Symptom-specific Evaluation Scale; C-HSES) was quantified based on living activities such as the presence or absence of symptoms and avoiding refrigeration, with the hand and mouth as target sites (total 24 points). We compared C-HSES with existing neuropathy evaluation indices (CTCAE JCOGver.4.02, Patient Neuropathy Questionnaire (PNQ), the Quick Disability of the Arm, Shoulder, and Hand (Quick DASH), and Numeric Rating Scale (NRS) for each chemotherapy cycle.

Results: Twenty-three patients were evaluated. The CHS showed deterioration over time on C-HSES (p < 0.001, ANOVA). C-HSES showed a significant correlation with NRS (p < 0.001, spearman). The C-HSES cutoff value indicating Grade ≥2 CTCAE was 12 points. It was able to detect Grade ≥2 CTCAE and Grade ≥D PNQ equivalent symptoms earlier than the existing indices (median duration of cold sensation was 9 vs. 22 courses, p < 0.046 vs. CTCAE Grade ≥2. 50% median cooling sensation period was 9 courses vs. not reached, p <0.001 vs. PNQ grade D).

Discussion: Existing indicators did not distinguish CHS from chronic PN, causing patients to experience distress. In effect, we may have underestimated the CHS-induced impairment of life. It was suggested that the C-HSES that we created could detect CHS (acute PN) peculiar to oxaliplatin, and thus can accurately apprehend the patient's distress. Thus, it was considered that the timing of drug withdrawal and dose reduction by PN could be optimized.

Conclusion: C-HSES is expected to be a tool that can detect CHS earlier for treatment than the existing evaluation indices and can be used as a tool for assessing patients' distress and disability