INSIDENSI, FAKTOR PREDIKTOR, DAN KLASTER GEJALA TOKSISITAS UMUM AKIBAT KEMOTERAPI PADA PASIEN KANKER PAYUDARA DI RSUP DR. SARDJITO BERDASARKAN PELAPORAN BERBASIS PASIEN

Juan Adrian Wiranata, dr. Susanna Hilda Hutajulu, Sp.PD-KHOM

2023 | Tesis | S2 Kedokteran Klinik

Tujuan Penelitian: penelitian ini bertujuan untuk mengamati profil dan klaster gejala toksisitas umum kemoterapi pada pasien kanker payudara, serta membentuk model prediksi gejala toksisitas umum yang berpengaruh terhadap (relative dose intensity) RDI suboptimal, dan mengamati faktor sosiodemografis dan klinikopatologis yanng berkorelasi dengan model prediksi.

Metode: Pasien dengan kanker payudara primer yang menjalani kemoterapi akan dinilai dengan instrumen Common Terminology Criteria for Adverse Events (CTCAE) versi 4.0 yang telah ditranslasi dan divalidasi digunakan untuk merekam insidensi dan severitas 26 gejala toksisitas umum. Analisis klaster dilakukan dengan menggunakan metode exploratory factor analysis (EFA). Pembentukkan model prediksi dilakukan dengan penghitungan skor terbobot dari masing-masing gejala toksisitas umum terhadap RDI suboptimal. Analisis kurva receiver operating characteristic (ROC) non-parametrik dan uji ekualitas area ROC dilakukan untuk menuntukan model prediksi yang terpilih. Analisis regresi logistik multivariabel dilakukan untuk mengamati korelasi antara faktor sosiodemografis dan klinikopatologis terhadap model prediksi.

Hasil: sebanyak 212 pasien dianalisis pada studi ini. Mayoritas dari gejala toksisitas umum merupakan severitas derajat 1 (81,9%), dimana anoreksia (95,8%), alopesia (95,8%) dan fatigue (95,3%) merupakan tiga gejala toksisitas umum dengan insidensi tertinggi. Hasil analsiis EFA mendapatkan tiga klaster gejala toksisitas umum diantaranya klaster gastrointestinal-epitelial-fatigue, klaster psikoneurologi, dan klaster nyeri. Terdapat perbedaan yang signifikan antara insidensi beberapa tipe gejala toksisitas umum kemoterapi berdasarkan regimen kemoterapi, dimana rejimen kombinasi antrasiklin-taksan mendominasi kejadian gejala toksisitas umum. Model prediksi dengan menggunakan skor terbobot dari gejala mulut kering, nyeri tenggorokan, dysgeusia, vomitus, dan sesak nafas, merupakan model terpilih yang memiliki diskriminasi yang baik terhadap RDI suboptimal. Status komorbiditas, dan riwayat pembedahan mastektomi merupakan faktor yang berkorelasi dengan model prediksi skor terbobot gejala toksisitas umum terhadap RDI suboptimal.

Kesimpulan: hasil dari studi ini menggarisbawahi pentingnya melakukan perekaman gejala toksisitas umum yang berbasis pelaporan pasien. Terdapatnya klaster gejala dan model prediksi terhadap RDI suboptimal menggarisbawahi pentingnya pengawasan dan manajemen pada gejala toksisitas umum.

Objective: This study aims to observe the profile and cluster of general (non-hematological) chemotherapy-induced toxicity in breast cancer patients, as well as to build a prediction model for general toxicity symptoms that are associated with suboptimal relative dose intensity (RDI) and explore the sociodemographic and pathological factors that are associated with the prediction model.

Methods: Patients with primary breast cancer undergoing chemotherapy will be assessed with the translated and validated Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 instrument used to record the incidence and severity of 26 common toxicity symptoms. Symptom cluster analysis was carried out using the exploratory factor analysis (EFA) method. The prediction model was formed by calculating the weighted score of each general toxicity symptom against suboptimal RDI. Non-parametric receiver operating characteristic (ROC) curve analysis and ROC area equality test were carried out to determine the selected prediction model. Multivariable logistic regression analysis was performed to observe the association between sociodemographic and clinicopathological factors in the prediction model.

Results: A total of 212 patients were described in this study. The majority of general toxicity symptoms were grade 1 in severity (81.9%), whereas anorexia (95.8%), alopecia (95.8%), and fatigue (95.3%) were the three general toxicity symptoms with the highest incidence. The results of the EFA analysis showed three clusters of general toxicity symptoms, including the gastrointestinal-epithelial-fatigue cluster, psychoneurological cluster, and pain cluster. There were significant differences between the incidence of several types of general toxicity symptoms of chemotherapy based on the chemotherapy regimen, whereas the anthracycline-taxane combination regimen dominated the incidence of general toxicity symptoms. The prediction model using weighted scores of symptoms of dry mouth, sore throat, dysgeusia, vomiting, and shortness of breath was the selected model that had good discrimination against suboptimal RDI. Comorbidity status and history of mastectomy disorders were factors that worsened the general toxicity symptom-weighted score prediction model against suboptimal RDI.

Conclusion: The results of this study underline the importance of recording common toxicity symptoms using patient-reported outcomes. The presence of cluster symptoms and prediction models for suboptimal RDI underscore the importance of monitoring and management of common toxicity symptoms.

Kata Kunci : Kanker Payudara, Kemoterapi, Gejala Toksisistas Umum, Pelaporan Berbasis Pasien, Klaster Gejala