ICORG 06-35: a prospective evaluation of PET-CT scan in patients with non-operable or non-resectable non-small cell lung cancer treated by radical 3-dimensional conformal radiation therapy: a phase II study.

BACKGROUND: Radiotherapy (RT) is a key treatment modality in the curative treatment of patients with non-small cell lung cancer (NSCLC). Incorrect definition of the gross, or clinical, target volume is a common source of error which can lead to a reduced probability of tumour control. OBJECTIVE: This was a pilot and a phase II study. The pilot evaluated the technical feasibility of integrating positron emission tomography-computed tomography (PET-CT) fusion. The primary outcome of the phase II study was to evaluate the safety of PET-CT scan-based RT by evaluating the rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV. METHODS: Patients underwent standard post-treatment follow-up, including repeated three monthly CT scans of the thorax. In case of loco-regional recurrence, three categories were considered, with only extra-PET scan PTV and intra-CT scan PTV recurrences considered as a failure. Our hypothesis was that the rate of these events would be < 10%. RESULTS: Twelve patients were recruited; the study closed early due to poor recruitment. The primary endpoint of the pilot was met; it was feasible to deliver a PET-CT-based plan to ≥ 60% of patients. Two patients had intra-PET scan PTV recurrences, six had extra-PET scan PTV and extra-CT, and three patients had both. Another patient had extra-PET scan PTV and extra-CT as well as extra-PET scan PTV and intra-CT scan PTV recurrence. CONCLUSION/ADVANCES IN KNOWLEDGE: PET-based planning has the potential to reduce radiation treatment volumes because of the avoidance of mediastinal lymph nodes that are PET negative.

The curative management of synchronous rectal and prostate cancer.

OBJECTIVE: Neoadjuvant "long-course" chemoradiation is considered a standard of care in locally advanced rectal cancer. In addition to prostatectomy, external beam radiotherapy and brachytherapy with or without androgen suppression (AS) are well established in prostate cancer management. A retrospective review of ten cases was completed to explore the feasibility and safety of applying these standards in patients with dual pathology. To our knowledge, this is the largest case series of synchronous rectal and prostate cancers treated with curative intent. METHODS: Eligible patients had synchronous histologically proven locally advanced rectal cancer (defined as cT3-4Nx; cTxN1-2) and non-metastatic prostate cancer (pelvic nodal disease permissible). Curative treatment was delivered to both sites simultaneously. Follow-up was as per institutional guidelines. Acute and late toxicities were reviewed, and a literature search performed. RESULTS: Pelvic external beam radiotherapy (RT) 45-50.4 Gy was delivered concurrent with 5-fluorouracil (5FU). Prostate total dose ranged from 70.0 to 79.2 Gy. No acute toxicities occurred, excluding AS-induced erectile dysfunction. Nine patients proceeded to surgery, and one was managed expectantly. Three relapsed with metastatic colorectal cancer, two with metastatic prostate cancer. Five patients have no evidence of recurrence, and four remain alive with metastatic disease. With a median follow-up of 2.2 years (range 1.2-6.3 years), two significant late toxicities occurred; G3 proctitis in a patient receiving palliative bevacizumab and a G3 anastomotic stricture precluding stoma reversal. CONCLUSION: Patients proceeding to synchronous radical treatment of both primary sites should receive 45-50.4 Gy pelvic RT with infusional 5FU. Prostate dose escalation should be given with due consideration to the potential impact of prostate cancer on patient survival, as increasing dose may result in significant late morbidity. Review of published series explores the possibility of prostate brachytherapy as an alternative method of boost delivery. Frequent use of bevacizumab in metastatic rectal cancer may compound late rectal morbidity in this cohort. ADVANCES IN KNOWLEDGE: To our knowledge, this is the largest case series of synchronous rectal and prostate cancers treated with curative intent. This article contributes to the understanding of how best to approach definitive treatment in these patients.