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Efikasi Penambahan Biocurcumin TM (BCM-95) pada Terapi Kanker Serviks Jenis Karsinoma Sel Skuamosa Stadium IIIB (Uji Klinis Fase IIB) = The Efficacy of Biocurcumin (BCM-95) as Addition Therapy in Stage IIIB Squamous Cell Carcinoma Cervical Cancer (Phase 2B Trial).

Terapi radiasi merupakan modalitas utama tata laksana kanker serviks stadium IIIB. Curcumin digunakan sebagai salah satu strategi pengobatan kanker dan radiosensitizer pada terapi kanker namun memiliki bioavailabilitas yang sangat lambat. Tujuan penelitian ini adalah melihat efikasi dan keamanan penambahan biocurcumin (BCM-95) pada kanker serviks stadium IIIB yang mendapatkan terapi radiasi. Penelitian uji klinis acak, tersamar ganda, dan berpembanding plasebo, melibatkan 119 pasien kanker serviks stadium IIIB karsinoma sel skuamosa di RSCM. Pasien dibagi menjadi dua kelompok: BCM-95 (n = 61) dan plasebo (n = 60), yang masing–masing menerima radioterapi dengan tambahan plasebo atau tiga kali 1000 mg BCM-95. Evaluasi efek terapi menggunakan kadar malondialdehyde (MDA), nuclear factor kappa B (NFkB), indeks apoptosis, dan respons terapi komplet (kriteria RECIST) berdasarkan MRI. Respons terapi komplet pada kelompok BCM-95 sebanyak 12 pasien (42,8%) dan pada kontrol 11 pasien (50%) dengan RR = 0,61 (0,87–1,4, p = 0,61). Terdapat aktivitas curcumin dalam meningkatkan kadar MDA, NF-kB, dan apoptosis meskipun secara statistik tidak terdapat perbedaan bermakna rerata kadar MDA, NF-kB, dan indeks apoptosis pascaradiasi pada kedua kelompok terapi.
Simpulan: Tidak terdapat perbedaan hasil terapi baik secara klinis maupun biomolekular pada pasien yang mendapatkan plasebo dan curcumin. Penambahan curcumin aman dalam terapi radiasi pasien kanker serviks
Kata kunci: biocurcumin, indeks apoptosis, kanker serviks, malondialdehyde, nuclear factor kappa B, respons terapi


Radiation therapy remains the main modality for treating stage IIIB cervical cancer. Curcumin has gained attention as one of the cancer treatment strategies as radiosensitizer, however curcumin has poor bioavailability. The purpose of this research was to study the efficacy and safety of biocurcumin (BCM-95) as an adjunct therapy for patients with cervical cancer in stage IIIB who received radiation therapy. This study was a randomized, double-blind, placebo-controlled clinical trial, included 119 patients newly diagnosed with stage IIIB cervical cancer squamous cell carcinoma at Cipto Mangunkusumo General Hospital Jakarta during 2014–2018. Patients were divided into two groups ID, BCM-95 (n = 60) and control (n = 59). Patients in intervention group were given 1000 mg BCM-95 three times a day. The assessments of therapy were carried out by the measurement of malondialdehyde (MDA), nuclear factor kappa B (NF-kB), apoptosis index, and clinical therapeutic response (RECIST criteria) by MRI. Complete response rate in group BCM-95 was 12 patients (42,8%) and control group was 11 patients (50%) with RR = 0,61 (0,87–1,4, p = 0,61). Curcumin can regulate the activity of MDA, NF-kB, and apoptosis in human cervical cancer although statistically show no difference between the two arms.
Conclusion: There is no clinical and biomolecular differences between placebo and biocurcumin. Curcumin is safe for cervical cancer patient treated by radiation.
Key words: apoptotic index, biocurcumin, cervical carcinoma, malondialdehyde, nuclear factor kappa B, therapeutic response