Pharmaceutical Industry Payments to Medical Oncologists in the Netherlands: Trends and Patterns Provided by an Open-Access Transparency Data Set.

PURPOSE: Health care expenditure related to oncologic treatments is skyrocketing although many treatments offer marginal, if any, clinical benefit. Financial conflicts of interest (fCOI) resulting from pharmaceutical industry (pharma) payments to physicians is increasingly recognized as a predictive factor for regulatory board approval and guideline incorporation of low-value treatments. We sought to study the extent to which pharma payments to medical oncologists occur in the Netherlands, the amount of money involved, and whether these occur more frequently and are higher for key opinion leaders (KOLs). METHODS: In our cross-sectional retrospective database study, we used several Dutch open-access databases and extracted data registered between 2019 and 2021. RESULTS: A cumulative amount of €899,863 was paid to 48.8% of the 408 registered medical oncologists. Over time, there was a marked decline in both the proportion of medical oncologists receiving payments (from 40.4% in 2019 to 19.1% in 2021) and the mean annual value of payments (from €2,962 in 2019 to €2,188 in 2021) with the latter mainly resulting from a decline in hospitality-related transactions. KOLs were more likely to receive industry payments and received a higher median payment value. DISCUSSION: Our findings should contribute to the increasing awareness in the Netherlands of the potential effects of fCOI.

Acute morbidity reduction using 3DCRT for prostate carcinoma: a randomized study.

PURPOSE: To study the effects on gastrointestinal and urological acute morbidity, a randomized toxicity study, comparing conventional and three-dimensional conformal radiotherapy (3DCRT) for prostate carcinoma was performed. To reveal possible volume effects, related to the observed toxicity, dose-volume histograms (DVHs) were used. METHODS AND MATERIALS: From June 1994 to March 1996, 266 patients with prostate carcinoma, stage T1-4N0M0 were enrolled in the study. All patients were treated to a dose of 66 Gy (ICRU), using the same planning procedure, treatment technique, linear accelerator, and portal imaging procedure. However, patients in the conventional treatment arm were treated with rectangular, open fields, whereas conformal radiotherapy was performed with conformally shaped fields using a multileaf collimator. All treatment plans were made with a 3D planning system. The planning target volume (PTV) was defined to be the gross target volume (GTV) + 15 mm. Acute toxicity was evaluated using the EORTC/RTOG morbidity scoring system. RESULTS: Patient and tumor characteristics were equally distributed between both study groups. The maximum toxicity was 57% grade 1 and 26% grade 2 gastrointestinal toxicity; 47% grade 1, 17% grade 2, and 2% grade > 2 urological toxicity. Comparing both study arms, a reduction in gastrointestinal toxicity was observed (32% and 19% grade 2 toxicity for conformal and conventional radiotherapy, respectively; p = 0.02). Further analysis revealed a marked reduction in medication for anal symptoms: this accounts for a large part of the statistical difference in gastrointestinal toxicity (18% vs. 14% [p = ns] grade 2 rectum/sigmoid toxicity and 16% vs. 8% [p < 0.0001] grade 2 anal toxicity for conventional and conformal radiotherapy, respectively). A strong correlation between exposure of the anus and anal toxicity was found, which explained the difference in anal toxicity between both study arms. No difference in urological toxicity between both treatment arms was found, despite a relatively large difference in bladder DVHs. CONCLUSIONS: The reduction in gastrointestinal morbidity was mainly accounted for by reduced toxicity for anal symptoms using 3DCRT. The study did not show a statistically significant reduction in acute rectum/sigmoid and bladder toxicity.

An analysis of anatomic landmark mobility and setup deviations in radiotherapy for lung cancer.

PURPOSE: To identify thoracic structures that exhibit little internal motion during irradiation and to determine setup variations in patients with lung cancer. METHODS AND MATERIALS: Intrafractional images were generated with an electronic portal-imaging device from the AP fields of 10 patients, during several fractions. To determine the intrafractional mobility of thoracic structures, visible structures were contoured in every image and matched with a reference image by means of a cross-correlation algorithm. Setup variations were determined by comparing portal images with the digitized simulator films using the stable structures as landmarks. RESULTS: Mobility was limited in the lateral direction for the trachea, thoracic wall, paraspinal line, and aortic notch, and in the craniocaudal direction for the clavicle, aortic notch, and thoracic.wall. Analysis of patient setup revealed random deviations of 2.0 mm (1 SD) in the lateral direction and 2.8 mm in the craniocaudal direction, while the systematic deviations were 2.5 and 2.0 mm (1 SD) respectively. CONCLUSIONS: We have identified thoracic structures that exhibit little internal motion in the frontal plane, and recommend that these structures be used for verifying patient setup during radiotherapy. The daily variation in the setup of lung cancer patients at our center appears to be acceptable.

Use of intraoperative neuromonitoring to prevent orbital complications in ethmoid sinus surgery.

Orbital injury is one of the most serious complications in sinus surgery. Although these injuries are generally infrequent, there is a considerable increased risk for orbital complications during procedures in which anatomic landmarks are distorted because of the severity of disease or prior surgery. Currently there are no methods to detect early defects in the lamina papyracea or to prevent continued resection until orbital fat or periorbita is seen. Thirteen New Zealand white rabbits were studied by use of a nerve monitor to identify the periorbita and orbital fat in surgically created lamina defects. Evoked potentials were measured at the medial orbit when the lamina papyracea, periorbita, and orbital fat were stimulated at current intensities ranging from 0.25 to 1.00 mA. Stimulation of the lamina at 0.8 and 1.0 mA resulted in response amplitudes that were significantly lower compared with those of periorbita stimulation (means at 1 mA, 38.26 microV vs. 117.85 microV; p < 0.01). Stimulation of the orbital fat also resulted in higher potentials (mean, 59.47 microV) than those of the lamina papyracea (mean, 38.26 microV) but did not reach statistical significance. The statistically significant difference in response amplitudes between the lamina papyracea and the periorbita indicate that intraoperative monitoring may be useful in identifying early lamina defects, which could in turn reduce the risk of orbital injury during sinus surgery.

Management of extended radionecrosis in the pelvic area with repeated surgical debridement and omental transposition.

Extended radionecrosis in the pelvic area is a disaster occurring in a minority of patients treated with radiotherapy. Extensive excisional procedures, including pelvic exenteration, have been recommended, but carry high morbidity and mortality rates. Alternative treatment strategies are needed to improve survival and increase the quality of life in these patients. We retrospectively analysed the charts of eight patients treated for radionecrosis in the pelvic area between 1985 and 1991. During this period deviatory procedures, repeated but limited debridement and the early incorporation of an omental flap in the ischemic area were used in an attempt to avoid exenteration, but effectively stop further progression of infection and necrosis. The patients underwent a median of five surgical interventions (range: 2 to 21) for 10 sites of radionecrosis. The total of 61 procedures consisted of debridement (29), omental pedicle grafting (6), deviation of urinary tract (3) or intestinal tract (4) and including procedures due to complications (21). They were hospitalized for a median duration of 95 days (range 43-155) divided over several admissions (median 3, range 2-8). One patient died of sepsis during treatment. Complete recovery was achieved in all surviving patients with a median of 12 months (range: 9 to 20 months) after initial surgery. Early surgery, the limited extent of the procedures and omental transposition were the main components of our approach. We conclude that this approach has an acceptable morbidity and mortality rate, while a relatively good quality of life is achieved.

Cutaneous squamous cell carcinoma occurring in a pectoralis major myocutaneous flap. Case report and literature review.

The pectoralis major myocutaneous flap is a reliable regional flap commonly used for the reconstruction of head and neck defects. We report a case of a squamous cell carcinoma that occurred on the cutaneous paddle of a pectoralis flap in a patient with previous chest wall lesions. The need for a careful history of previous chest wall cutaneous lesions is stressed in patients who are to undergo this type of reconstruction.

Preservation of the facial nerve in the management of recurrent pleomorphic adenoma.

Whether to preserve or sacrifice a facial nerve involved with benign neoplasm is one of the most difficult intraoperative decisions confronting the head and neck surgeon. We reviewed 21 cases of recurrent pleomorphic adenoma treated with subtotal excision and facial nerve preservation, followed by postoperative radiation therapy. Of the 17 patients with microscopic residual tumor at completion of surgery, 16 (94%) remain free of recurrence with an average follow-up of 5.9 years. Only one of four patients (25%) with a large postoperative tumor load remains free of disease. Facial nerve function is normal in 20 of 21 patients. Preservation of the facial nerve with postoperative irradiation should be considered as an alternative to nerve sacrifice in selected cases of recurrent pleomorphic adenoma.

Phase II study of bleomycin, dacarbazine (DTIC) and vindesine in disseminated malignant melanoma.

Thirty-one patients with disseminated malignant melanoma were treated with a combination chemotherapy of bleomycin, dacarbazine and vindesine. Five complete responses, and five partial remissions occurred. One patient survived for over 2 years without evidence of disease. This combination of drugs may give better results, as far as complete recovery and long-term survival are concerned, than single-agent therapy with dacarbazine.