The patient advisor, an organizational resource as a lever for an enhanced oncology patient experience (PAROLE-onco): a longitudinal multiple case study protocol.

BACKGROUND: Quebec is one of the Canadian provinces with the highest rates of cancer incidence and prevalence. A study by the Rossy Cancer Network (RCN) of McGill university assessed six aspects of the patient experience among cancer patients and found that emotional support is the aspect most lacking. To improve this support, trained patient advisors (PAs) can be included as full-fledged members of the healthcare team, given that PA can rely on their knowledge with experiencing the disease and from using health and social care services to accompany cancer patients, they could help to round out the health and social care services offer in oncology. However, the feasibility of integrating PAs in clinical oncology teams has not been studied. In this multisite study, we will explore how to integrate PAs in clinical oncology teams and, under what conditions this can be successfully done. We aim to better understand effects of this PA intervention on patients, on the PAs themselves, the health and social care team, the administrators, and on the organization of services and to identify associated ethical and legal issues. METHODS/DESIGN: We will conduct six mixed methods longitudinal case studies. Qualitative data will be used to study the integration of the PAs into clinical oncology teams and to identify the factors that are facilitators and inhibitors of the process, the associated ethical and legal issues, and the challenges that the PAs experience. Quantitative data will be used to assess effects on patients, PAs and team members, if any, of the PA intervention. The results will be used to support oncology programs in the integration of PAs into their healthcare teams and to design a future randomized pragmatic trial to evaluate the impact of PAs as full-fledged members of clinical oncology teams on cancer patients' experience of emotional support throughout their care trajectory. DISCUSSION: This study will be the first to integrate PAs as full-fledged members of the clinical oncology team and to assess possible clinical and organizational level effects. Given the unique role of PAs, this study will complement the body of research on peer support and patient navigation. An additional innovative aspect of this study will be consideration of the ethical and legal issues at stake and how to address them in the health care organizations.

Azacitidine-induced pyoderma gangrenosum at injection sites in a patient with myelodysplastic syndrome.

Pyoderma gangrenosum (pg) is a rare neutrophilic dermatosis characterized by painful necrotic ulceration affecting preferentially the lower extremities. Diagnosis is challenging, and a thorough workup (including biopsy) is required. In this case report, we describe a 67-year-old patient with a diagnosis of myelodysplastic syndrome (mds) who developed fever and pg two days after the first cycle of subcutaneous azacitidine (Vidaza; Celgene Corporation, Summit, NJ, USA). On physical examination, the patient had four erythematous plaques at sites of subcutaneous injections of azacitidine on the arms, as well as three other plaques in proximity. A skin biopsy demonstrated a dense neutrophilic interstitial infiltrate in the dermis. After the diagnosis of pg, prednisone 1 mg/kg was started and the fever subsided rapidly. This was followed by the resolution of the cutaneous lesions. Changing the route of administration of azacitidine from subcutaneous to intravenous and adding a daily dose of prednisone during the treatment allowed the patient to receive a total of 10 cycles of azacitidine. This is the second case reported in the literature. Because azacitidine is frequently used in mds and acute myeloid leukemia, clinicians should be aware of this rare cutaneous adverse event. Our approach can be used to avoid the recurrence of pg when continuing azacitidine treatment.

Prognosis in young women less than 40 years of age with brain metastasis from breast cancer.

Background: Brain metastasis from breast cancer (bca) in young women is doubly devastating because both quality of life and life expectancy are significantly reduced. With new radiation technology and drugs that have emerged, survival is expected to increase for these young women. Methods: Using the oacis and sardo patient databases, we identified 121 patients diagnosed with bca and brain metastasis between 2006 and 2016 at the University of Montreal Hospital Centre. Those patients were divided into Group A, patients who developed brain metastasis during the evolution of metastatic bca, and Group B, patients whose first metastasis was to the brain. For each group, we compared young patients (<40 years of age) with older patients (≥40 years of age). Results: Among the 121 patients with brain metastasis, median overall survival (mos) was significantly longer for those less than 40 years of age than for those 40 or more years of age (18 months vs. 4 months, p < 0.001). With respect to the timing of brain metastasis, survival was significantly longer in Group B than in Group A (7 months vs. 4 months, p = 0.032). In Group A, mos was significantly longer for patients less than 40 years of age than for patients 40 or more years of age (18 months vs. 3 months, p = 0.0089). In Group B, the 2-year overall survival rate was 57% for patients less than 40 years of age and 12% for those 40 or more years of age (mos: not reached vs. 7 months; p = 0.259). Conclusions: In our single-centre retrospective cohort of women with brain metastasis from bca, prognosis was better for young women (<40 years) than for older women (≥40 years). Survival was also longer for patients whose initial metastasis was to the brain than for patients whose brain metastasis developed later in the disease course. In patients who received systemic treatment, median survival remained significantly higher in women less than 40 years of age. Further studies are needed to validate those results.

Combined results of two phase II studies of Taxol (paclitaxel) in patients with relapsed or refractory lymphomas.

This study was performed to determine the clinical activity and safety of paclitaxel in the treatment of patients with refractory or relapsing aggressive Non-Hodgkin's lymphoma (NHL). Between May 3, 1994 and February 16, 1996, 39 patients with refractory or relapsing NHL consented to be enrolled in two, multicenter, open-labelled studies to evaluate the efficacy, safety, time to progression and overall survival of paclitaxel given at a dose of 175 mg/m2 by a 3-hour IV infusion every three weeks without G-CSF use. Data from the two studies is combined. One patient, although registered, did not receive treatment. Of the remaining 38 patients, 17 men and 21 women aged 26-82 years (median 60) were given 104 courses of paclitaxel [median 2 (range 1-6)]. Seventeen patients had stage IV, 7 stage III, 8 stage II, 5 stage 1 and 1 unknown stage of disease. Histologic grades included 1 low, 33 intermediate, and 4 high. Three patients had bone marrow involvement. Median time from diagnosis to study entry was 19 months (1-160). The median number of previous chemotherapy regimens was 2 (range 1-6). Three of the 35 (8.6%) patients evaluable for response had partial remission (PR) of their disease for 1-7 months (median 2) and 11/35 (31.4%) stable disease (SD) for 1 to 19 months (median 3). All three responders and 3 of the 11 SD patients had received paclitaxel after relapsing from a CR. At analysis, nine of the 38 patients were alive. Median duration of follow up at analysis was 6 months (3 days-29 months). The estimated survival rates for all patients at 1 and 2 years are 34% and 27%, respectively (Kaplan-Meier) from the start of paclitaxel treatment. The median survival time was 5.4 months (3 days to 28+ months). Febrile neutropenia occurred in two patients. Seven (18%) patients developed a neutrophil nadir of < 0.5 x 10(9)/L and 2 (5%) patients developed a platelet nadir of < 50 x 10(9)/L. Six patients received blood transfusions. Non-hematologic toxicity was generally mild to moderate with all patients experiencing some toxicity. Twenty-seven patients experienced grade III toxicity including: alopecia (n = 19), pain (n = 9), fatigue (n = 5), nausea/vomiting (n = 3), diarrhoea (n = 2), pulmonary/shortness of breath (n = 2), anorexia (n = 1) and fluctuating levels of consciousness and somnolence (n = 1). Two patients experienced grade IV toxicity (infection, peripheral neuropathy, pain). No patient discontinued paclitaxel for a severe hypersensitivity reaction. In summary, administered as a 3-hour infusion, paclitaxel 175 mg/m2 results in mild myelotoxicity but minimal antitumor activity in patients with refractory NHL.

Hot needle thermal keratoplasty to correct naturally occurring hyperopic astigmatism.

OBJECTIVE: To study the safety, effectiveness, predictability and stability of sectoral thermal keratoplasty in the treatment of naturally occurring hyperopic astigmatism. METHODS: Using Fyodorov's technique, sectoral controlled coagulations were applied on both sides of the flattest meridian in 12 eyes from eight patients with naturally occurring hyperopic astigmatism. Preoperative average refractive cylinder was +3.19 +/- 1.13 diopters (D), and the mean spherical component was +0.71 +/- 1.03 D. Mean follow-up time was 13.2 months. RESULTS: Immediately after surgery, we observed a significant overcorrection in the treated meridian in all patients. Then, a gradual decrease of the refractive effect was noticed, since the average refractive astigmatism was +0.25 +/- 1.23 D at 6 months and +1.15 +/- 0.86 at 12 months after surgery. At 1 month after surgery, the mean shift in the cylinder axis was 83.75 degrees +/- 8.82 degrees and 12.08 degrees +/- 12.33 degrees at the 1-year examination. Uncorrected visual acuity was 20/40 or better in all patients 1 year after surgery. We did not observe severe corneal complications, such as irregular astigmatism or delayed epithelial wound healing. CONCLUSION: Hot needle sectoral thermal keratoplasty appears to be safe and partially effective in reducing hyperopic astigmatism, but considerable postoperative regression may occur.

Refractive results of radial keratotomy after 10 years.

BACKGROUND: We analyzed retrospectively the refractive and visual results of a cohort of patients who underwent radial keratotomy for myopia 10 years ago. METHODS: Radial keratotomies using centripetal incisions were performed by the same surgeon in 1986 and 1987 to correct myopia of -0.75 to -10.00 diopters (D). Refractive and visual results were evaluated at 1 month and on average 10 years after surgery. RESULTS: Thirty-nine patients (71 eyes) underwent radial keratotomy. Mean spherical equivalent refraction before surgery was -3.90 D and after surgery was -0.50 D at 1 month and +0.13 D at 10 years after surgery. At last examination, 41 eyes (43.7%) had a spherical equivalent refractive error within +/- 1.00 D of emmetropia (24 eyes [34%] +/- 0.50 D) and 32.4% of eyes were overcorrected by more than 1.00 D. Between 1 month and 10 years after surgery, a hyperopic shift greater than 1.00 D occurred in 34.1% of eves with a single procedure. Ten years after surgery, 59 eyes (83%) had uncorrected distance visual acuity of 20/40 or better (22 eyes [31%] with uncorrected visual acuity of 20/20 or better). CONCLUSION: This retrospective evaluation confirms that radial keratotomy is an effective procedure to correct myopic error, but the hyperopic shift produces an unstable, less predictable refraction in one-third of eyes at 10 years.

[Exfoliative syndrome and cataract surgery]. / Syndrome exfoliatif et chirurgie de la cataracte.

In the present prospective study, we compared the results of cataract surgery in two groups with or without exfoliation syndrome; 210 eyes were studied. The preoperative pupillary dilatation was smaller in the group with exfoliation syndrome (SE). We noticed a higher incidence of complications during planned extracapsular cataract extraction in patients with SE. A pupillary diameter smaller than 6 mm increases the incidence of capsulozonular rupture (22.5%) in these patients. After surgery, an inflammatory reaction and a transient increase in intraocular pressure were more frequent and the visual results were less favourable in the group with SE. The exfoliation syndrome is a major risk factor for cataract surgery. We recommend extracapsular extraction associated with a sector iridectomy when the pupillary diameter measures less than 6 mm.

[Post-traumatic fat embolism. Apropos of a case]. / Embolie graisseuse post-traumatique. A propos d'une observation.

We describe the clinical, ophthalmoscopic, angiographic, and perimetric findings of fat embolism occurring in one patient with diaphysare femoral fracture. Fundus examination disclosed a bilateral cotton-wool spot retinopathy. Fluorescein angiography showed a masking effect of the cotton-wool spots. Visual field testing did not show scotoma in damaged areas of the retina.

[Intrastromal thermokeratoplasty for correction of spherical hyperopia: a 1-year prospective study]. / Thermokératoplastie intrastromale pour la correction de l'hypermétropie sphérique: étude prospective à un an.

Thermokeratoplasty (TKP) is a new procedure for surgical correction of hyperopia. It uses controlled thermal burns of the peripheral cornea with a retractable cautery probe tip in a radial pattern up to a premarked optical central zone. The thermal effect shrinks the peripheral cornea and steepens the central cornea. In this report, we prospectively evaluated for one year, anatomical, functional and refractive results of a group of 18 eyes treated with TKP (14 patients). Mean preoperative spherical equivalent of +3.62 diopters (D) was +1.85 D at 12 months resulting in a mean refractive variation of -1.76 D. The refractive effect was significant at the first postoperative month, and subsequently regressed so that the average refractive correction was 55% at one year. We did not observe any severe anatomical or functional complications during the follow up period. Regression of the refractive effect after TKP seems to be related to the remodeling response of corneal stroma surrounding points of coagulation. Like other current techniques of surgical correction of hyperopia (hexagonal keratotomy, TKP using Holmium-YAG laser, Excimer laser), TKP is a procedure for which optical results at one year show poor predictability and stability. We suggest that adjustments to the surgical prediction software and long term studies would allow to improve our results.

[Conjunctival epidermoid carcinoma and human immunodeficiency virus]. / Carcinome épidermoïde conjonctival et virus de l'immunodéficience humaine.

We describe the clinical and histopathological findings of a conjunctival squamous cell carcinoma occurring in a patient with acquired immunodeficiency syndrome (AIDS). The excisional biopsy specimen disclosed a papillar, well differentiated and mature squamous cell carcinoma with microinvasion. The biopsy was studied for the presence of Human papilloma virus DNA by using in situ hybridization but no signal was demonstrated in any part of the tumour. Although Kaposi's sarcoma and non-Hodgkin's lymphomas are the most common malignancies reported in AIDS, squamous cell carcinomas may be encountered in the disease. Underlying infection with the human immunodeficiency virus should be considered when conjunctival localization of such malignancies is observed.

[Acute open-angle glaucoma in a woman with AS hemoglobinopathy]. / Glaucome aigu à angle ouvert chez une femme porteuse d'une hémoglobinopathie AS.

A 64-year-old black woman presented unilateral acute ocular hypertension. Gonioscopy showed a blood clot obstructing Schlemm's canal. Intraocular pressure returned to normal values after resorption of the blood clot. Hemoglobin electrophoresis found a sickle-cell trait, raising the hypothesis that the obstruction of outflow was probably due to the mechanism of sickling.

[Fuchs' uveitic syndrome in a patient with ocular toxoplasmosis]. / Syndrome uvéitique de Fuchs chez une patiente porteuse d'une toxoplasmose oculaire.

We report a case of Fuchs' uveitic syndrome associated with toxoplasmic chorioretinis scars, and a positive Desmonts' coefficient. This allows us to emphasize ocular toxoplasmosis as a main association to be searched for clinically. In the cases in which this association is found, it would be warranted, if a high level of specific antitoxoplasmic antibodies is demonstrated in aqueous humor, to consider toxoplasmosis as one of the potential etiopathogenic factors of the Fuchs' uveitic syndrome.

[Small cell carcinoma of the ovary. A clinical and anatomo-pathologic entity]. / Le carcinome à petites cellules de l'ovaire. Une entité clinique et anatomopathologique.

Small cell carcinoma of the ovary is a rare histological form which is highly malignant. We have decided to consider this as an epithelial tumour after studying it with the optical and the electron microscope. It is however difficult to put it in to a definite type because it is highly undifferentiated. On the clinical level small cell carcinoma is different from other ovarian cancers in several respects. Whereas ovarian tumours usually tend to occur in menopausal women in the fifth or sixth decade of life, small cell carcinomas of the ovary occur mainly in younger women of ages between 10 and 38 years. Furthermore, women who are attacked by this kind of a carcinoma tend to die very soon after the diagnosis has been made without receiving any benefit from the many therapies that have been tried to improve the prognosis. We have studied the condition after seeing two cases of small cell carcinoma in the University Gynaecological Department of Tours, and we have made a study of the literature. We have studied the therapeutic angle for these tumours and we have tried to find out what the best technique will be to cope with this awful prognosis. We discuss whether it might be worthwhile in future to intensify therapy in combination with bone marrow autotransplantation.

Temozolomide in metastatic breast cancer (MBC): a phase II trial of the National Cancer Institute of Canada - Clinical Trials Group (NCIC-CTG).

BACKGROUND: Temozolomide is an oral alkylating agent that crosses the blood-brain barrier, and has preclinical activity in breast cancer. This phase II trial sought to determine the activity and toxicity of temozolomide in metastatic breast cancer (MBC). Temozolomide was administered in a dose dense schedule of 150 mg/m(2) on days 1-7 and 15-21 in a 28-day cycle. MATERIALS AND METHODS: Patients had unidimensional disease for response assessment by RECIST criteria, up to two prior chemotherapy regimens for MBC, and may have had brain metastases if radiation was not expected to be required within 4 weeks. RESULTS: Nineteen women were entered on the study. All were evaluable for toxicity and 18 were evaluable for response. The median age was 54 years; 14 had prior chemotherapy for MBC and 12 had prior hormones. Sites of disease included bone, brain, liver and lung. Treatment was well tolerated with 14/19 receiving >90% planned dose intensity. Common grade 1-3 drug-related effects included nausea, fatigue, vomiting, anorexia and skin rash. Grade 3-4 hematologic toxicities included granulocytopenia and thrombocytopenia. Of the 18 evaluable patients, there were no objective responses; three had stable disease and 15 progressive disease. CONCLUSIONS: No responses to temozolomide were documented in these heavily pretreated women with extensive MBC including brain metastases.

Phase I study of Aplidine in a dailyx5 one-hour infusion every 3 weeks in patients with solid tumors refractory to standard therapy. A National Cancer Institute of Canada Clinical Trials Group study: NCIC CTG IND 115.

BACKGROUND: Aplidine is a cyclic depsipeptide isolated from the marine tunicate Aplidium albicans. METHODS: This phase I study of Aplidine given as a 1-hour i.v. infusion daily for 5 days every 3 weeks was conducted in patients with refractory solid tumors. Objectives were to define the dose limiting toxicities, the maximal tolerated dose, and the recommended phase II dose. RESULTS: Thirty-seven patients were accrued on study. Doses ranged from 80 microg/m(2) to 1500 microg/m(2)/day. Eleven patients received more than three cycles of Aplidine. Dose-limiting toxicities occurred at 1500 microg/m(2) and 1350 microg/m(2)/day and consisted of nausea, vomiting, myalgia, fatigue, skin rash and diarrhea. Mild to moderate muscular pain and weakness was noted in patients treated with multiple cycles with no significant drug related neurotoxicity. Bone marrow toxicity was not observed. The recommended dose for phase II studies was 1200 microg/m(2) daily for 5 days, every 3 weeks. Pharmacokinetic studies performed during the first cycle demonstrated that therapeutic plasma levels of Aplidine are reachable well below the recommended dose. Nine patients with progressive disease at study entry had stable disease and two had minor responses, one in non-small cell lung cancer and one in colorectal cancer. CONCLUSIONS: Aplidine given at a dose of 1200 microg/m(2) daily for 5 days, every 3 weeks is well tolerated with few severe adverse events. This schedule of Aplidine is under evaluation in phase II studies in hematological malignancies and solid tumors.

Increased hepatotoxicity of carbon tetrachloride by the hypolipidemic drug nafenopin in rats.

Pretreatment of rats with the potent hypolipidemic drug nafenopin enhanced the hepatotoxicity of carbon tetrachloride as judged by the serum activity of glutamic pyruvic transaminase (SGPT), hepatic triglyceride content and glucose-6-phosphatase activity as well as by light and electronmicroscopy. Nafenopin alone caused an increase in liver weight, proliferation of peroxisomes and of smooth endoplasmic reticulum in hepatocytes. No marked changes of serum SGPT activity were observed, but hepatic glucose-6-phosphatase activity decreased. Results suggest that the hypolipidemic compound can act on endoplasmic reticulum membranes so that they become more susceptible to the attack by carbon tetrachloride or it(s) metabolite(s).