Realizing Our Common Goodness: One Sacred Encounter at a Time.

Co-sponsored by the Benedictine Sisters of Yankton, South Dakota, and the Presentation Sisters of Aberdeen, South Dakota, Avera Health was established in 2000 when the two congregations joined as one health ministry to serve the greater South Dakota area and four surrounding states.

Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group.

OBJECTIVE: Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks. STUDY DESIGN: Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial. SETTING: Twenty-one investigational sites across the United States. SUBJECTS AND METHODS: Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. RESULTS: Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire-7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%). CONCLUSIONS: The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.

Patient and surgeon radiation exposure in balloon catheter sinus ostial dilation.

OBJECTIVE: The aim of this study was to determine the extent of radiation exposure to the patient and the surgeon in balloon catheter dilation. METHODS: Dosimeters were used to record radiation exposure to both patients and surgeons. The mean radiation dose per sinus treated and per patient treated was calculated for each dosimeter location. RESULTS: The mean patient dose (108 sinuses treated in 34 patients), was 0.32 mSv per sinus and 1.02 mSv per patient over the eye and 1.33 mSv per sinus and 4.22 mSv per patient over the temple. The average total fluoroscopy time was 3.6 minutes per patient. The average number of sinuses treated was 3.2. The mean surgeon dose at the chest (254 sinuses in 89 patients) was 0.025 mSv per sinus and 0.072 mSv per patient. The mean surgeon dose at the hand (182 sinuses in 68 patients) was 0.009 mSv per sinus and 0.023 mSv per patient. CONCLUSIONS: The use of fluoroscopy in balloon catheter dilation exposes both the patient and surgeon to very low doses of radiation.

Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up.

OBJECTIVE: Assess two-year postoperative clinical outcomes for patients receiving balloon catheter sinusotomy. METHODS: Patients who had sinus ostia dilated with balloon catheters were prospectively evaluated two years after surgery by Sinonasal Outcome Test (SNOT-20) and computed tomographic (CT) scan. RESULTS: Sixty-five patients (195 ballooned sinuses) were followed for two years after surgery, including 34 "balloon-only" patients and 31 "hybrid" patients. SNOT-20 symptom scores were significantly improved from baseline (0.87 vs 2.17 baseline, P < 0.001) and stable compared to six months and one year; this was the case for both balloon-only (1.09 vs 2.09, P < 0.001) and hybrid (0.64 vs 2.26, P < 0.001) patients. Lund-MacKay CT scores were significantly improved from baseline (2.69 vs 9.66, P < 0.001) and stable compared to one year, confirmed for both balloon-only (1.75 vs 5.67, P < 0.015) and hybrid (3.25 vs 12.05, P < 0.001) subsets of patients. A total of 85% of patients reported improvement of their sinus symptoms, with 15% same and 0% worsened. Revision treatment was required in seven of 195 sinuses (3.6%) in six of 65 patients (9.2%). CONCLUSION: Patients who receive balloon catheter sinusotomy in endoscopic sinus surgery have significant improvement in symptoms two years after surgery. Radiographic evidence also confirms resolution of disease after two years. This demonstrates durability of clinical results previously reported at 24 weeks and one year after surgery.

Balloon catheter sinusotomy: one-year follow-up--outcomes and role in functional endoscopic sinus surgery.

OBJECTIVE: The primary objective was to assess the long-term effectiveness of balloon catheter sinusotomy. METHODS: Patients who had sinus ostia dilated with balloon catheters were prospectively evaluated 1 year after surgery with nasal endoscopy, a CT scan, and the Sino-Nasal Outcome Test (SNOT-20). RESULTS: Sixty-six patients (202 sinuses) were examined. One hundred seventy-two of 202 sinus ostia (85%) were endoscopically patent, 1 percent (2/202) were nonpatent, and ostial patency could not be determined by endoscopy in 28 of 202 (14%). In these "indeterminate" sinuses, the CT scans were normal in 13, implying functional patency in 91.6 percent of sinuses (185/202). Sinus CT scan scores were 1.95 at 1 year versus 8.89 at baseline (P < 0.001), and 1-year SNOT-20 scores (0.91) were significantly improved from baseline (2.14, P < 0.0001). CONCLUSION: Balloon catheter sinusotomy results were durable over the study period, showing long-term effectiveness.

Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients.

OBJECTIVES: This study assesses the safety and effectiveness of balloon catheters used as instruments in sinus surgery in a "real-world" multicenter registry of 1,036 patients across 27 US otolaryngology practices. METHODS: Data were collected by standardized chart review with centralized database administration for all consecutive functional endoscopic sinus surgeries that included the use of balloon catheters across the 18-month time period from December 2005 to May 2007. RESULTS: Balloon catheters were used in 3,276 peripheral (maxillary, frontal, and sphenoid) sinuses, for an average of 3.2 sinuses per patient. There were no major adverse events related to the use of balloon catheter instruments. The revision rate was 1.3% of sinuses treated with a balloon catheter after an average follow-up of 40.2 weeks. Sinus symptoms were improved in 95.2%, unchanged in 3.8%, and worse in 1.0% of patients. Postoperative sinus infections were significantly less frequent and less severe compared to infections before surgery. The results were consistent across all patient categories, including balloon-only patients and revision patients. CONCLUSIONS: Use of balloon catheters as instruments in sinus surgery appears to be relatively safe and effective and to improve the patient's quality of life. The results are consistent and generalizable across a wide range of sinusitis patients and physician practices. The complication rates, revision rates, and patient symptom improvement rates all compare favorably with previously reported results of functional endoscopic sinus surgery.

Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial.

OBJECTIVES/HYPOTHESIS: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. STUDY DESIGN: In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. METHODS: The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. RESULTS: Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire-7 Symptom scores at 6-week follow-up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube. CONCLUSIONS: This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:1200-1206, 2018.

Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients.

OBJECTIVE: The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy. METHODS: Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20). RESULTS: At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%). CONCLUSION: Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.

Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis.

BACKGROUND: Endoscopic posterior nasal nerve (PNN) resection has been described as an efficacious surgical treatment of allergic and nonallergic rhinitis, but the requirement for surgery under general anesthesia has limited its acceptance. We report the first series of patients treated for chronic rhinitis using a novel device designed for office-based cryosurgical ablation of the PNN. METHODS: Twenty-seven patients with chronic rhinorrhea and/or nasal congestion for >3 months were recruited (allergic or nonallergic rhinitis), with minimum rhinorrhea and/or congestion subscores of 2 as part of the Total Nasal Symptom Score [TNSS]). Under local anesthesia, the cryotherapy device was applied endoscopically to the posterior middle meatus and was used to freeze the PNN region bilaterally. Patients were followed up after 7, 30, 90, 180, and 365 days to assess TNSS. RESULTS: The procedure was successfully completed in 100% of patients, with no complications; 74% reported no or mild discomfort by the first postprocedure day. TNSS was reduced significantly at 30 days (mean ± standard deviation: 6.2 ± 0.5 at baseline, 2.6 ± 0.3 at 30 days, n = 27, p < 0.001), with continued reduction at 90 (2.7 ± 0.4, n = 24, p < 0.001), 180 (2.3 ± 0.5, n = 21, p < 0.001), and 365 days (1.9 ± 0.3, n = 15, p < 0.001). Both rhinorrhea and congestion subscores decreased significantly at 30, 90, 180, and 365 days compared to baseline (p < 0.001). Allergic and nonallergic subcohorts both appeared to benefit from treatment. CONCLUSION: Office-based cryotherapy of the PNN region is safe and well tolerated. Symptom scores were significantly decreased by 7 days postprocedure and remained lower at 30, 90, 180, and 365 days.

Dermatologic toxicity of chemotherapeutic agents.

Due to its high metabolic rate, skin represents one of the major target organs of chemotherapy-associated toxicity. Reactions range from common, nonspecific exanthematous eruptions to rare but distinctive cutaneous lesions that may not become apparent until a drug transitions from clinical trials to widespread oncologic use. The challenge of the physician is to recognize reaction patterns that reflect a drug reaction, identify a likely causative drug, and determine whether the reaction is a dose-limiting toxicity. This review will focus on the cutaneous side effects of the newer classes of chemotherapy drugs, including targeted monoclonal antibody therapy and small molecule inhibitors.

Resonance Raman spectroscopy of oxoiron(IV) porphyrin pi-cation radical and oxoiron(IV) hemes in peroxidase intermediates.

The catalytic cycle intermediates of heme peroxidases, known as compounds I and II, have been of long standing interest as models for intermediates of heme proteins, such as the terminal oxidases and cytochrome P450 enzymes, and for non-heme iron enzymes as well. Reports of resonance Raman signals for compound I intermediates of the oxo-iron(IV) porphyrin pi-cation radical type have been sometimes contradictory due to complications arising from photolability, causing compound I signals to appear similar to those of compound II or other forms. However, studies of synthetic systems indicated that protein based compound I intermediates of the oxoiron(IV) porphyrin pi-cation radical type should exhibit vibrational signatures that are different from the non-radical forms. The compound I intermediates of horseradish peroxidase (HRP), and chloroperoxidase (CPO) from Caldariomyces fumago do in fact exhibit unique and characteristic vibrational spectra. The nature of the putative oxoiron(IV) bond in peroxidase intermediates has been under discussion in the recent literature, with suggestions that the Fe(IV)O unit might be better described as Fe(IV)-OH. The generally low Fe(IV)O stretching frequencies observed for proteins have been difficult to mimic in synthetic ferryl porphyrins via electron donation from trans axial ligands alone. Resonance Raman studies of iron-oxygen vibrations within protein species that are sensitive to pH, deuteration, and solvent oxygen exchange, indicate that hydrogen bonding to the oxoiron(IV) group within the protein environment contributes to substantial lowering of Fe(IV)O frequencies relative to those of synthetic model compounds.

Natural history of more than 20 years of node-positive primary breast carcinoma treated with cyclophosphamide, methotrexate, and fluorouracil-based adjuvant chemotherapy: a study by the Cancer and Leukemia Group B.

PURPOSE: Breast cancer heterogeneity dictates lengthy follow-up to assess outcomes. Efficacy differences for three regimens that are based on adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) are presented in this article, but cancer recurrence sites, time of relapse, subsequent primary cancers, and causes of death in the natural history of node-positive breast cancer are emphasized. PATIENTS AND METHODS: Beginning in 1975, 905 patients with node-positive cancer were randomly assigned to receive CMF or two regimens of CMF plus other agents. Median follow-up is 22.6 years. The natural-history analysis was performed on a subset of 814 patients. RESULTS: Eighty percent of the 599 women known to have died, died of metastatic breast cancer. Only 8.5% of the deceased women died of a cause other than breast cancer, a second or third cancer, or adjuvant chemotherapy toxicity. One hundred five women (12.8%) developed other primary cancers, with 49 (46.6%) occurring in the contralateral breast. Therapeutic efficacy differences of the CMF regimens reported earlier have been maintained more than 20 years later. For certain subsets, the five-drug regimen had advantages over CMF. Bone was the most common recurrence site. The longest interval to relapse has been 23.5 years, and 18% of those who relapsed did so more than 10 years later. CONCLUSION: Despite adjuvant chemotherapy, a large majority (80%) of women with node-positive breast cancer die of the disease, and many recurrences develop more than 10 years later. CMF plus vincristine and prednisone provides a benefit compared with CMF, but the magnitude varies with the number of involved nodes. Outcome trends in earlier analyses of this study were maintained even years later.

Adjuvant chemotherapy in older and younger women with lymph node-positive breast cancer.

CONTEXT: Adjuvant chemotherapy improves survival for patients with local-regional breast cancer, but healthy older patients at high risk of recurrence are frequently not offered adjuvant chemotherapy, and the benefit of adjuvant chemotherapy in older patients is uncertain. OBJECTIVE: To compare the benefits and toxic effects of adjuvant chemotherapy among breast cancer patients in age groups of 50 years or younger, 51 to 64 years, and 65 years or older. DESIGN AND SETTING: Retrospective review of data from 4 randomized trials that accrued patients from academic and community medical centers between 1975 and 1999. Median follow-up for all patients was 9.6 years. All trials randomized patients to different regimens, doses, schedules, and durations of chemotherapy and all had a treatment arm with doses or schedules that were regarded to be "high" and potentially more toxic. PATIENTS: A total of 6487 women with lymph node-positive breast cancer; 542 (8%) patients were 65 years or older and 159 (2%) were 70 years or older. MAIN OUTCOME MEASURE: Comparison of disease-free survival, overall survival, and treatment-related mortality among different age groups. RESULTS: Multivariate analysis showed that smaller tumor size, fewer positive lymph nodes, more chemotherapy, and tamoxifen use were all significantly (P<.001) related to longer disease-free and overall survival. There was no association between age and disease-free survival. Overall survival was significantly (P<.001) worse for patients aged 65 or older because of death from causes other than breast cancer. Thirty-three deaths (0.5% of all patients) were attributed to treatment, and older women had higher treatment-related mortality. Older women and younger women derived similar reductions in breast cancer mortality and recurrence from regimens containing more chemotherapy. CONCLUSION: Age alone should not be a contraindication to the use of optimal chemotherapy regimens in older women who are in good general health.

New cisplatin analogues in development. A review.

Cisplatin was discovered to have cytotoxic properties in the 1960s, and by the end of the 1970s it had earned a place as the key ingredient in the systemic treatment of germ cell cancers. Since the early seminal work in the preclinical and clinical development of this drug, several thousand analogues have been synthesised and tested for properties that would enhance the therapeutic index of cisplatin. About 13 of these analogues have been evaluated in clinical trials, but only one (carboplatin) has provided definite advantage over cisplatin and achieved worldwide approval. However, carboplatin has afforded benefit only in reducing some cisplatin toxicities; it has not enlarged the spectrum of platinum-sensitive cancers, nor has it proved active in cisplatin-resistant cancers. The major obstacle to the efficacy of cisplatin or carboplatin is platinum resistance, either innate or acquired. The mechanisms of this resistance have been under intense study, and many of the cisplatin analogues synthesised in the past decade have been designed specifically with the hope of overcoming platinum resistance. The mechanism of the cytotoxic activity of platinum complexes has also been studied intensely. Recently synthesised analogues have been designed to interact with DNA in a manner different from cisplatin and carboplatin, with the desire of finding new structures with a superior or wider spectrum of antitumor efficacy. Most recently, water soluble platinum complexes that retain antitumour activity, but that can be effectively absorbed after oral administration, have been synthesised with the goal of improving patient quality of life. Nine platinum analogues are currently in clinical trials around the world (ormaplatin [tetraplatin], oxaliplatin, DWA2114R, enloplatin, lobaplatin, CI-973 [NK-121], 254-S, JM-216 and liposome-entrapped cis-bis-neodecanoato-trans-R,R-1,2-diaminocyclohexane platinum (II) [LNDDP]). Some of these analogues only represent attempts to reduce cisplatin toxicity and/or allow administration without forced hydration and diuresis, which carboplatin already does. Others are 'third generation' complexes shown to have limited or no cross-resistance with cisplatin in preclinical studies. They are being tested clinically with particular attention to this highly desirable property.(ABSTRACT TRUNCATED AT 400 WORDS)

Biphenyl-Strapped Diphenylporphyrins: Synthesis and Spectroscopic Characterization of a Series of Porphyrins with Ether-Linked Straps. Preliminary CO Binding Properties of Their Iron(II) Derivatives.

The synthesis of a series of meso-5,15-diphenylporphyrins strapped by 2,2'-disubstituted biphenyl units (6H(2), 7H(2), 8H(2)) is described. The biphenyl straps used are linked via their 3,3'-positions by CH(2)O groups to ortho-positions of the phenyl rings of the 5,15-diphenylporphyrins. The straps of these porphyrins have their 2,2'-positions occupied by H (6H(2)), Me (7H(2)), and OMe (8H(2)). The electronic spectral properties of these strapped porphyrins are given, and their conformational properties, which have been studied by (1)H NMR spectroscopy, are described. The synthesis and spectroscopic characterization of several iron(II) and iron(III) derivatives of these porphyrins with different axial bases are also presented. The X-ray structure of the chloroiron(III) derivative of the diphenylporphyrin dianion 6 has been determined. Violet crystals of composition 6-FeCl.CH(3)OH.CH(2)Cl(2) have been obtained by slow evaporation of CH(2)Cl(2)/MeOH solutions of 6-FeCl. These crystals belong to the monoclinic system, space group P2(1)/c, with a = 10.164(3) Å, b = 28.977(9) Å, c = 14.283(4) Å, beta = 106.22(2) degrees, and Z = 4. The iron atom of 6-FeCl is five-coordinate, high-spin. The axial chloride ligand lies opposite to the strap. The average Fe-N(p) bond distance is 2.046(6) Å, and the Fe-Cl bond length equals 2.234(2) Å. The porphyrin is slightly domed and ruffled with the iron atom lying at 0.45(1) Å out of the 4N(p) mean-plane and 0.49(1) Å out of the 24-atom core mean-plane of the porphyrin ring. Ferrous carbonyl adducts of these porphyrins have been obtained in various solvents in the presence or absence of nitrogenous bases. Their structures have been studied by (1)H NMR and IR spectroscopy. Two CO stretching vibrations differing by 20 cm(-)(1) occur in the IR spectra of 6-Fe(CO)(B) (B = py, ImH, NMeIm). The possible origin of these two nu(CO) bands is discussed.

Four-Coordinate, Low-Spin (S = 0) and Six-Coordinate, High-Spin (S = 1) Nickel(II) Complexes of Tetraphenylporphyrins with beta-Pyrrole Electron-Withdrawing Substituents: Porphyrin-Core Expansion and Conformation.

To examine the porphyrin-core expansion and the conformational variations induced by a change in the coordination sphere of nickel(II) from four-coordinate, low-spin (S = 0) to six-coordinate, high-spin (S = 1), several nickel(II) derivatives of tetraphenylporphyrins, substituted in their beta-pyrrole positions with electron-withdrawing groups, were isolated and studied by X-ray crystallography. The four-coordinate nickel(II) complex studied, Ni(TPP(Br)(4)(CN)(4)) (1), is a derivative of the antipodal beta-pyrrole brominated and cyanated macrocycle, 2,3,12,13-tetrabromo-7,8,17,18-tetracyano-5,10,15,20-tetraphenylporphyrin. One of the six-coordinate species is the bis-pyridine nickel(II) adduct, Ni(TPP(Br)(4)(CN)(4))(py)(2) (2), of this antipodal beta-pyrrole brominated and cyanated ring, whereas the second six-coordinate complex is the bis-1-methylimidazole nickel(II) adduct, Ni(TPP(CN)(4))(1-MeIm)(2) (3), of the antipodal tetracyanated macrocycle, 7,8,17,18-tetracyano-5,10,15,20-tetraphenylporphyrin. This study confirms that, upon conversion of a four-coordinate, low-spin nickel(II) derivative of a beta-pyrrole-substituted tetraphenylporphyrin into a six-coordinate, high-spin complex, a radial expansion of the porphyrin core also takes place. This radial expansion flattens the porphyrin core, inducing more planarity in the conformations of the six-coordinate nickel(II) porphyrin species. The X-ray structure of 1 reveals an average Ni-N(p) bond distance of 1.920(2) Å, similar to that present in tetragonal Ni(OEP) [(Ni-N(p))(av) = 1.929(3) Å], the ruffled low-spin nickel(II) (S = 0) porphyrin derivative, and many other low-spin nickel(II) complexes of distorted porphyrins. The conformation of the macrocycle present in 1 is severely saddle-shaped with a small ruffling and a minor doming. The structures of 2 and 3 indicate a clear expansion of the porphyrin cores with two sets of (Ni-N(p))(av) bond lengths of 2.040(2) and 2.073(2) Å in 2 and 2.037(2) and 2.068(2) Å in 3, which differ significantly from the average Ni-N(p) distance occurring in 1. Relative to the conformation of the porphyrin ring present in 1, the high-spin complex 2 is less saddle-shaped, but more ruffled. In 3, in which only two opposite pyrrole rings of the porphyrin are substituted by cyano groups, the macrocycle adopts a slightly waved conformation. Crystal data: Ni(TPP(Br)(4)(CN)(4)).2.5(1,2-Cl(2)C(2)H(4)), [1.2.5(1,2-Cl(2)C(2)H(4))], triclinic, space group P&onemacr;, a = 13.741(1) Å, b = 14.029(2) Å, c = 15.201(2) Å, alpha = 89.037(9) degrees, beta = 70.829(8) degrees, gamma = 67.607(8) degrees, V = 2539.4(5) Å(3), T = 20 degrees C, Z = 2, R(F)() = 0.047 and R(wF) = 0.067 based on 5341 reflections with I > 3sigma(I); Ni(TPP(Br)(4)(CN)(4))(py)(2).2.5(1,2-Cl(2)C(2)H(4)), [2.2.5(1,2-Cl(2)C(2)H(4))], triclinic, space group P&onemacr;, a = 11.9472(9) Å, b = 14.3651(7) Å, c = 19.556(1) Å, alpha = 87.049(5) degrees, beta = 73.181(6) degrees, gamma = 70.613(5) degrees, V = 3026.8(4) Å(3), T = 173 K, Z = 2, R(F)() = 0.036, R(wF) = 0.041 based on 6846 reflections with I > 3sigma(I); Ni(TPP(CN)(4))(1-MeIm)(2).2CH(2)Cl(2), [3.2(CH(2)Cl(2))], monoclinic, space group C2/c, a = 26.804(8) Å, b = 10.948(3) Å, c = 19.453(5) Å, beta = 113.13(2) degrees, V = 5251.5 Å(3), T = 20 degrees C, Z = 4, R(F)() = 0.047, R(wF) = 0.067 based on 4384 reflections with I > 3sigma(I).

Long-term adjustment of survivors of early-stage breast carcinoma, 20 years after adjuvant chemotherapy.

BACKGROUND: The long-term impact of breast carcinoma and its treatment was assessed in 153 breast carcinoma survivors previously treated on a Phase III randomized trial (Cancer and Leukemia Group B [CALGB 7581]) a median of 20 years after entry to CALGB 7581. METHODS: Survivors were interviewed by telephone using the following standardized measures: Brief Symptom Inventory (BSI), PostTraumatic Stress Disorder Checklist with the trauma defined as survivors' response to having had cancer (PCL-C), Conditioned Nausea, Vomiting and Distress, European Organization for Research and Treatment of Cancer QLQ-C30 (quality of life), Life Experience Survey (stressful events), MOS Social Support Survey, comorbid conditions (Older Americans Resources and Services Questionnaire), and items developed to assess long-term breast carcinoma treatment side effects and their interference with functioning. RESULTS: Only 5% of survivors had scores that were suggestive of clinical levels of distress (BSI), 15% reported 2 or more posttraumatic stress disorder (PTSD) symptoms (PCL-C) that were moderately to extremely bothersome, 1-6% reported conditioned nausea, emesis, and distress as a consequence of sights, smells, and tastes triggered by reminders of their treatment, 29% reported sexual problems attributed to having had cancer, 39% reported lymphedema, and 33%, reported numbness. Survivors who reported greater lymphedema and numbness that interfered with functioning had significantly worse PTSD (PCL-C; P = 0.008) com- pared with survivors who reported less lymphedema and numbness. Survivors with a lower level of education (P = 0.026), less adequate social support (P = 0.0033), more severe negative life events (P = 0.0098), and greater dissatisfaction with their medical care (P = 0.037) had worse PTSD compared with other survivors. CONCLUSIONS: Twenty years after the initial treatment, the impact of breast carcinoma on survivors' adjustment was minimal. However, the higher prevalence of PTSD symptoms in response to having had cancer is indicative of continuing psychologic sequelae long after treatment completion. Findings related to lymphedema and numbness and continued symptoms of PTSD suggest that the long-term psychologic and medical sequelae on adjustment may be underrecognized. To establish in more detail whether survivors' overall psychologic state is any different from that of individuals without cancer, a population of community residents without cancer would need to be studied.