Phase III Study Combines SBRT and Sorafenib in Hepatocellular Carcinoma


Laura A. Dawson, MD, FRCPC, of Princess Margaret Cancer Centre, Toronto, and colleagues evaluated whether the addition of stereotactic body radiation therapy (SBRT) to sorafenib treatment might improve survival outcomes in patients with hepatocellular carcinoma. The results of this trial, presented during the 2023 American Society of Clinical Oncology (ASCO) GI Cancers Symposium (Abstract 489), suggest that SBRT improved both progression-free and overall survival compared with sorafenib alone and did not increase the frequency of adverse events.

The investigators focused on 177 patients with newly diagnosed or recurrent hepatocellular carcinoma who were deemed unsuitable for surgery or ablation. Participants were randomly assigned to receive sorafenib alone (n = 92) or following SBRT (n = 85).

The median patient age was 66 years, and 40% of patients had a single hepatocellular carcinoma. With a median follow-up of 13.2 and 33.7 months for all and living patients, respectively, 22% of individuals received SBRT after discontinuing sorafenib. There were 153 overall survival events, and the median overall survival was improved from 12.3 months with sorafenib alone to 15.8 months when combined with SBRT; median progression-free survival improved from 5.5 to 9.2 months (P = .0001).

Adverse events included eight cases of grade 3 or higher bleeding, affecting five patients and three patients in the sorafenib and SBRT-plus-sorafenib arms, respectively. Although prevalent, treatment-related adverse events of grade 3 or higher did not statistically differ between groups (42% vs. 47%). Adverse events of grade 5 included hepatic failure, lung infection, and death (n = 1 each). Of note, 35% of patients given SBRT plus sorafenib reported having an improved quality of life compared with 10% given sorafenib alone.

Source: JNCCN

Is IMRT Before Surgery of Benefit in Patients With Centrally Located Liver Cancer?


The use of neoadjuvant intensity-modulated radiotherapy (IMRT) before surgical resection of hepatocellular carcinoma with a hepatectomy may be an efficacious and tolerable treatment option for patients with centrally located disease, according to a study published in JAMA Surgery. However, additional investigative efforts are warranted to determine the extent of this approach’s efficacy, suggested Jianxiong Wu, MD, of the Peking University Cancer Hospital and Institute, China, and colleagues.

From 2014 to 2019, a total of 38 patients with centrally located hepatocellular carcinoma were recruited for the nonrandomized, controlled study. All patients had Child-Pugh class A liver function and had not received any previous treatment. They received liver-directed neoadjuvant IMRT over a 5- to 6-week period, and their status was subsequently discussed at a multidisciplinary team meeting to determine the best surgical approach.

The study findings revealed that 34.2% of patients reached a major pathologic response after treatment. From this cohort, 13.2% of patients reached a complete pathologic response. In addition, there was a 94.6%, 75.4%, and 69.1% overall survival rate at 1-, 3-, and 5-year intervals, respectively. A 45.8-month median disease-free survival rate was reported, with patients achieving 70.3%, 54.1%, and 41.0% disease-free survival rates at 1-, 3-, and 5-year intervals.

Moreover, 7.9% of patients experienced grade 3 radiotherapy-related adverse effects. Furthermore, complications from surgical intervention were observed in 34.2% of patients. They included grade 1 to 2 complications (31.6%) and grade 3a complications (2.6%). More severe complications were not observed in any patients, according to the investigators.

Source: JNCCN

ASCO GI 2023: Palliative Radiotherapy for Canadian Patients With Pain From Liver Cancer


A phase III study conducted by Laura A. Dawson, MD, FRCPC, of Princess Margaret Cancer Centre, Toronto, and colleagues offered palliative radiotherapy to patients with symptomatic hepatocellular cancer and liver metastases in an attempt to alleviate their pain. The results of their study, which were presented during the 2023 American Society of Clinical Oncology (ASCO) GI Cancers Symposium (Abstract LBA492), suggest that single-fraction radiotherapy improves hepatic pain and survival better than supportive care in most patients.

This multicenter trial focused on 66 patients with painful hepatocellular carcinoma (n = 23) or liver metastases (n = 43). Participants were randomly assigned to receive best supportive care alone or with single-fraction radiotherapy at 8 Gy. Eligibility criteria required individuals to have end-stage disease and to be unsuitable for local, regional, or systemic therapies.

Of the total, 42 patients on radiotherapy (n = 24) and best supportive care (n = 18) completed assessments at baseline and 1 month; the average “pain at worst” score at baseline was 7 of 10. Approximately 67% of patients on radiotherapy reported an improved “worst” pain score after 1 month on treatment, compared with 22% of those on best supportive care (P = .004). Of note, 21% on radiotherapy and 0% on best supportive care had improved pain, with no increase in opioid use (P = .07).

There was a larger percentage of patients reporting a significant improvement in “pain at its least” (P = .03) and “percentage relief in pain by treatment” (P = .04) on radiotherapy than that of those on best supportive care. Additionally, a sensitivity analysis revealed significant improvements in “worst pain” among participants treated with radiotherapy (P = .002). Although grade 3 or higher adverse events were uncommon, 58% and 33% of individuals in the radiotherapy and best supportive care arms experienced events of at least grade 2. Of note, treatment with radiotherapy correlated with improved 3-month survival (P = .07).

Source: JNCCN

Focused Treatment of Solitary Prostate Cancer Metastases Without Hormone Blockers


According to a study published in The Journal of Urology, metastasis-directed treatment without androgen deprivation therapy has emerged as a potential alternative for men with a solitary oligorecurrent prostate cancer. In the metastasis-directed treatment approach, surgery or stereotactic body radiation therapy (SBRT) is used specifically to target the area of cancer spread.

“Metastasis-directed therapy has been a controversial approach to management of solitary metastatic recurrences of prostate cancer,” said Jack R. Andrews, MD, of Mayo Clinic Arizona, Phoenix, in a press release. “Our study is the first to show benefits of both surgical and radiation therapy metastasis-directed treatment without [androgen-deprivation therapy] in this group of patients, potentially delaying the need for systemic treatment.”

Dr. Andrews and colleagues focused on 124 patients with a solitary metastatic lesion on C-11 choline PET imaging whose primary tumor has already been treated to explore outcomes of metastasis-directed treatment without concomitant androgen-deprivation therapy from 2008 to 2018. Metastasis-directed treatment consisted of either SBRT or surgical excision.

Results showed that both types of focused treatment were effective in terms of biochemical recurrence. This was reflected by reduction in prostate-specific antigen (PSA) levels. After surgery, PSA levels decreased by about half in 80.5% of patients after metastasis-directed treatment. Most patients eventually needed androgen-deprivation therapy or other systemic therapy for progressive cancer. However, at 3-year follow-up, 29% of patients were alive and free from cancer progression. In the radiation therapy group, 40.3% of patients had a reduction in PSA levels by half.

Therefore, these results suggest that metastasis-directed treatment without androgen-deprivation therapy may delay initiation of systemic therapy. It also highlights the need for further prospective studies of select patients with solitary metastatic recurrences of prostate cancer.

Source: JNCCN