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がん臨床試験ジャーナル

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音量 1, 問題 2 (2016)

研究論文

Rationale and Design of a Trial for Prophylactic Nutritional Support (Pronus) During Treatment for Head and Neck Cancer: A Single-Center, Randomized, Controlled Trial Comparing Effects of Percutaneous Endoscopic Gastrostomy Tube and Nasogastric Tube Placement on Nutritional Status of Patients

M Aasim Yusuf, Faisal Zeb, M Qayyum Khan, Syed Raza Hussain, Hala Mansoor, M Adnan Masood, Arif Jamshed and Waleed Zafar

Background: Prophylactic nutritional support of head and neck cancer patients being treated with chemoradiation through placement of either a percutaneous endoscopic gastrostomy (PEG) tube or a nasogastric (NG) tube is well-established in clinical care. There is, however, little scientific evidence to support one over the other.

Methods: We planned to conduct a randomized controlled trial to compare the effects of PEG tube or NG tube on nutritional status and quality of life of patients; the rates of clinical complications; and the cost of care. The trial was conducted at a tertiary care cancer specialist center in Lahore, Pakistan.

Results: The study was closed early because of refusal of eligible patients to be randomly assigned to the NG arm of the study. 7 patients were assessed for eligibility of whom 2 withdrew from the study after one week in the NG arm and 5 refused to be randomized to the NG arm.

Conclusion: We concluded that NG tube placement is not an appropriate first-line option for prophylactic nutritional support among head and neck cancer patients at our center and should not be offered.

レビュー

Updates in the Use of the mTOR Inhibitor Everolimus in Advanced Breast Cancer

Jennifer Anderson and Sandra Cuellar

The inhibitors of mammalian target or rapamycin (mTOR) exhibit antitumor activity via disruption of various signaling pathways and have shown activity when used in combination with hormonal therapy in breast cancer. A review of the role of the efficacy and management of adverse effects of everolimus in combination with exemestane in advanced breast cancer was previously reported by Ng and colleagues. The purpose of this commentary is to provide an update on the efficacy and safety of everolimus in advanced breast cancer, as well as explore the prognostic role of biomarkers. Since 2012, there has been an update on the efficacy of BOLERO-2 as well as an examination of biomarkers. Additionally, everolimus has been investigated in other settings for advanced breast cancer. An update on the adverse effect profile and management of stomatitis associated with everolimus is also provided.

研究論文

Hepatic Resection for Breast Cancer Liver Metastases

Jorge P Grondona, Adrián Hannois, Ricardo A Bracco, Pedro J Angiolini, Ignacio G Merlo, Roberto Acevedo, Diego Enrico and Jeannette Burton

Aim: To review the experience of a single Oncological Surgery Centre regarding the benefit of hepatic resection in breast cancer liver metastases (BCLM) patients with unique focus in overall survival rate, and compare these results with matched individuals of other group of BCLM patients treated only with chemotherapy and/or hormonal regimens.

Patients and methods: Between July 2007 and July 2015, a total of 260 female patients with BCLM were entered prospectively into a database of our Surgical Oncological Centre, and were all evaluated by their Multidisciplinary Team. Two groups of patients were enlisted: 1) Surgical Group (SG) enrolled by 36 patients which were suitable to receive a hepatic resection; 2) Non-Surgical Group (NSG) integrated by 20 that could receive medical treatment alone. Patients with 5 or more liver metastases and/or uncontrolled extra hepatic metastatic disease were excluded in this series. However, patients with slight extra hepatic disease that were treated and were deemed stable or certainly improving were included.

Results: Concerning with SG there was no postoperative mortality and perioperative complications occurred in 11 out of 36 patients (30.5%). Histopathological examination confirmed in all cases free tumor margin (R0). Followup of 100% for all patients. Median overall survival was 55.2 months in the SG vs 23.6 months in the NSG. Actuarial 1-year, 3-year and 5-year survival rates were 100%, 84% and 61.6% respectively in the SG vs 65%, 28% and 0% respectively in the NSG (p=0.000).

Conclusions: Surgical treatment is only indicated in a select group of patients and can improve long-term outcomes. In this study, significantly better survival rates were observed in the surgical group that encourage continuing in this line of multimodal treatment. Surgical therapy can act as an effective adjuvant treatment to systemic therapies, providing selected patients a survival benefit as well as the hope for cure.

解説

A Clearance Step will become Increasingly Crucial for Pretargeted Tumor Therapy when Tumor Accumulation is Improved

Guozheng Liu

This is a commentary on a paper we published in Cancer Biother Radiopharm 2010. This commentary addresses related concerns about adding a separate clearing agent in the pretargeted tumor therapy. Previous investigations of tumor pretargeting mostly focused on utilizing the characteristic rapid clearance of a small therapeutic effector to limit toxicity exposure to normal tissues, but at a price of reduced tumor accumulation. Nevertheless, at least in theory, this reduction of tumor accumulation is not inevitable. The effector structure should be able to be modulated for its highest tumor accumulation while keeping the normal tissue background of the free effector negligible. However, so far little effort has been made in this area. In connection with the reduction of the toxicity to normal tissues, inclusion of a clearing step is well known. This commentary is to indicate that, in the pretargeted tumor therapy, inclusion of a clearance step will be more crucial when tumor accumulation of the effector is improved. It is the prerequisite to redeem the benefit of improved tumor accumulation.

レビュー

Adjuvant Therapy for Resected Exocrine Pancreatic Cancer by Half-Body Low-Dose Irradiation

Jerry M. Cuttler, Philippe Garzon, Ron E. J. Mitchel, Ludwig E. Feinendegen, Kiyohiko Sakamoto and James S. Welsh

After surgery, pancreatic cancer has an extremely high rate of systemic recurrence and a very high rate of local recurrence, more than 80 percent and 20 percent, respectively. Conventional adjuvant therapy prolongs median survival, 28 versus 15 months, by eliminating many of the metastases before they grow into new tumours. In an effort to improve outcomes, the authors recommend evaluating half-body low-dose irradiation (HB LDI) therapy because limited clinical studies have shown HB LDI to be successful as an adjuvant treatment for different types of cancer. Each dose fraction in LDI therapy is 15 cGy, about 13 times below the 200 cGy dose fraction employed in each normal (high-dose) radiation treatment to destroy cancer cells. The LDI mechanism is stress-related repeated stimulation of the patient's very powerful adaptive protection systems by repeated exposure of the patient's upper body to a low dose of radiation. Five weeks of applying this repetitive stress to the patient appears to prolong the enhanced cancer-cell-killing and tissue repair for many months. A booster of this treatment after six months would extend the stimulation for years. This therapy can be started immediately after surgery because it also promotes tissue healing and has no adverse symptomatic side effects. Since adjuvant chemotherapy would normally start within four to six weeks after resection, there is little risk of a delay in providing HB LDI therapy and evaluating its benefit. In most cases the serum marker CA 19-9 can be monitored. If the effectiveness of this therapy is judged to be inadequate, then conventional adjuvant therapies would be provided.

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