How does spirituality manifest in family caregivers of terminally ill cancer patients? A qualitative secondary analysis.

OBJECTIVE: Considering the risk of spiritual distress among terminally ill patients, experts long agree that spiritual care has to be an integral component of palliative care. Despite this consensus, the role of spirituality among family caregivers remains largely unexplored. We aimed to describe how spirituality manifests in the lived experience of family caregivers (FCs) in a palliative care context. METHOD: As part of a secondary analysis, data derived from two qualitative primary studies on FCs' burdens and needs in the context of caring for a patient with a diagnosis of incurable cancer. Previously transcribed interviews were examined by means of a thematic analysis, transcending the focus of the primary studies to examine how spirituality arises and/or persists in the life of FCs from the time of diagnosis of incurable cancer up until bereavement. RESULTS: Twenty-nine narratives were explored and all included spirituality as a relevant theme. Analysis revealed four aspects associated with the presence of spirituality among FCs' experiences: "Connectedness," "Religious Faith," "Transcendence," "Hope," and a fifth overarching aspect which we named "Ongoing integration of spiritual experience." Spirituality appeared as a multilayered phenomenon and was shaped individually among FCs' narratives. SIGNIFICANCE OF RESULTS: In view of the results, exploring and discussing spirituality and underlying experiences in the situation as an FC seems likely to widen the perspective on FCs' problems and needs. Further research on spiritual needs among FCs of patients with incurable life-limiting cancer is deemed necessary.

[Support for and involvement of family caregivers in Comprehensive Cancer Center - an Assessment of the Palliative Care Working Group within the network of Comprehensive Cancer Center funded by the German Cancer Aid]. / Mitbetreuung und Einbeziehung von Angehörigen in Comprehensive Cancer Centern ­ eine Erhebung der AG Palliativmedizin der von der Deutschen Krebshilfe geförderten Onkologischen Spitzenzentren.

BACKGROUND: According to current oncological guidelines, early integration of specialist palliative care (SPC) represents standard cancer care supporting not only the patients, but also their family caregivers. Data on the actual implementation in daily oncology practice in Germany are lacking. METHODS: The Palliative Care Working Group of the network of Comprehensive Cancer Centers certified by the German Cancer Aid (CCC) assessed the implementation of measures for family caregiver support and involvement within the CCC/within SPC in the CCC/local outside the CCC in all 17 CCC locations. RESULTS: In the CCC/in SPC psycho-oncological (100 %/94 %), social (94 %/100 %) and spiritual counselling of family caregivers (94 % each) as well as support for children with parental cancer (88 %/100 %) and information materials for family caregivers (88 % each) are well established. Training on nursing skills (77 %/94 %) and family conferences (59 %/88 %) are established more frequently within SPC than in the rest of the CCC. SOPs are rather rare (23 %/18 %) as well as screenings for family caregiver needs (0/24 %). Bereavement or self-help groups are with 82 % each more frequent locally outside the CCC. Psycho-oncological and social counselling as well as support for children with parental cancer were scored as most important (94 % each). For SPC, training on nursing skills and information materials were rated equally (94 % each). SOPs were rated as very/extremely important in 47 %/41 % and routine screening for family caregiver in 53 %/65 %. CONCLUSION: In correspondence to their importance, psychosocial and spiritual counselling and support for children with parental cancer are well implemented in CCC. In SPC, training on nursing skills and family conferences are also well implemented. SOPs for family caregiver support and involvement as well as routine screenings for family caregiver needs have to be implemented urgently in the CCC.

Symptom Burden and Palliative Care Needs of Patients with Incurable Cancer at Diagnosis and During the Disease Course.

BACKGROUND: Although current guidelines advocate early integration of palliative care, symptom burden and palliative care needs of patients at diagnosis of incurable cancer and along the disease trajectory are understudied. MATERIAL AND METHODS: We assessed distress, symptom burden, quality of life, and supportive care needs in patients with newly diagnosed incurable cancer in a prospective longitudinal observational multicenter study. Patients were evaluated using validated self-report measures (National Comprehensive Cancer Network Distress Thermometer [DT], Functional Assessment of Cancer Therapy [FACT], Schedule for the Evaluation of Individual Quality of Life [SEIQoL-Q], Patients Health Questionnaire-4 [PHQ-4], modified Supportive Care Needs Survey [SCNS-SF-34]) at baseline (T0) and at 3 (T1), 6 (T2), and 12 months (T3) follow-up. RESULTS: From October 2014 to October 2016, 500 patients (219 women, 281 men; mean age 64.2 years) were recruited at 20 study sites in Germany following diagnosis of incurable metastatic, locally advanced, or recurrent lung (217), gastrointestinal (156), head and neck (55), gynecological (57), and skin (15) cancer. Patients reported significant distress (DT score ≥ 5) after diagnosis, which significantly decreased over time (T0: 67.2%, T1: 51.7%, T2: 47.9%, T3: 48.7%). The spectrum of reported symptoms was broad, with considerable variety between and within the cancer groups. Anxiety and depressiveness were most prevalent early in the disease course (T0: 30.8%, T1: 20.1%, T2: 14.7%, T3: 16.9%). The number of patients reporting unmet supportive care needs decreased over time (T0: 71.8 %, T1: 61.6%, T2: 58.1%, T3: 55.3%). CONCLUSION: Our study confirms a variable and mostly high symptom burden at the time of diagnosis of incurable cancer, suggesting early screening by using standardized tools and underlining the usefulness of early palliative care. IMPLICATIONS FOR PRACTICE: A better understanding of symptom burden and palliative care needs of patients with newly diagnosed incurable cancer may guide clinical practice and help to improve the quality of palliative care services. The results of this study provide important information for establishing palliative care programs and related guidelines. Distress, symptom burden, and the need for support vary and are often high at the time of diagnosis. These findings underscore the need for implementation of symptom screening as well as early palliative care services, starting at the time of diagnosis of incurable cancer and tailored according to patients' needs.

Assessing palliative care need in left ventricular assist device patients and heart transplant recipients.

OBJECTIVES: Palliative care (PC) has gained rising attention in a holistic treatment approach to chronic heart failure (HF). It is unclear whether there is a need for PC in left ventricular assist device (LVAD) patients or heart transplant recipients. METHODS: In a cross-sectional explorative pilot study, outpatients after heart transplantation (HTx, n = 69) or LVAD implantation (n = 21) underwent screening for palliative care (PC) need and evaluation of symptom burden and psychological distress using tools that emanated from palliative cancer care. RESULTS: The 'Palliative Care Screening Tool for Heart Failure Patients' revealed scores of 4.3 ± 2.2 in HTx and 6.0 ± 2.1 in LVAD patients (max. 12 points, P = 0.003), indicating the need for PC (≥5 points) in 32% of HTx and 67% of LVAD patients. Symptom burden, as assessed by MIDOS ('Minimal Documentation System for Palliative Care') scores was substantial in both groups (4.9 ± 4.7 in HTx vs 6.6 ± 5.3 in LVAD, max. 30 points, P = 0.181). 'Fatigue', 'weakness' and 'pain' were the most frequent symptoms. Using the 'Distress-Thermometer', 'clinically relevant' distress was detected in 57% of HTx and 47% of LVAD patients (P = 0.445). In the PHQ-4 ('4-Item Patient Health Questionnaire'), 45% of LVAD patients, compared to only 10% of HTx patients, reported mild symptoms of anxiety and depression. CONCLUSIONS: Findings reveal substantial need for PC in LVAD patients and, to a lesser extent, in heart transplant recipients, suggesting that multi-disciplinary PC should be introduced into routine aftercare.

Tipping point: When patients stop eating and drinking in the last phase of their life.

BACKGROUND: Eating and drinking are essential also in social life. Nutrition and hydration (N&H) at end of life are often a source of discussion and distress. Stopping eating and drinking is a defining element of the dying phase, however, this time point is not well defined. The aim of this retrospective analysis was to investigate whether such a time point can be detected, whether there are specific characteristics associated. METHODS: The time point when patients stopped oral intake was analyzed in relation to time until death on a specialist palliative care ward (sPCW) of a tertiary comprehensive cancer center. This "tipping point" (TP) was defined as the time point when total food intake fell below 25% of normal solid intake (TP-S) and "tipping point fluid" (TP-F) when fluid intake fell below 500 ml/day (oral/intravenous/subcutaneous). Demographic and medical data, the N&H-module in the electronic patient management system and the daily multiprofessional treatment notes at TP (±3 days) were analyzed in all patients cared on the sPCW between 1/15 and 9/17. RESULTS: In these 32 months, of 1194 treated patients 683 (57%) died on the ward. A TP-S was identified in 291 patients prior to dying on the ward (43%) with a median time of six days from to TP-S death. In 75% of these patients, TP-S occurred within two weeks prior to death (range: 0-5 weeks). A TP-F was detected in 202 patients (30%) with a median TP-F-time of two days prior to death. In 75% of these patients, the TP-F was within three days prior to death (range: 0-14 days). The cancer entities in patients in whom TPs could be detected were heterogeneous. No specific disease-related or sociodemographic characteristics for patients with TPs could be determined. In the daily treatment notes, oral and swallowing problems, taste alterations and discussions about stopping artificial nutrition were mentioned. CONCLUSION: In less than half of dying patients a definitive TP could be detected. In these patients, TP-S occurred within two weeks and TP-F within few days before death. No specific characteristics of patients with TPs could be observed. This indicates the individual nature of the trajectory at end of life.

Standard Operating Procedures (SOPs) for Palliative Care in German Comprehensive Cancer Centers - an evaluation of the implementation status.

BACKGROUND: The working group for palliative medicine within the Comprehensive Cancer Center (CCC) network funded by the German Cancer Aid in Germany has developed and published 14 Standard Operating Procedures (SOPs) for palliative care in CCCs. This study analyzed to what extent these SOPs have been implemented in the clinical routine in the CCC network one year after their publication. METHODS: An online-based survey on the implementation status, limitations in daily practice and further themes was conducted between April and July 2018. In total, 125 health professionals in specialized palliative care from all 16 CCC locations were invited to participate. The data were analyzed descriptively using SPSS. RESULTS: The response rate was 52.8%. More than half of the respondents (57.6%) knew about the free availability of SOPs on the CCC network website. The extent to which each SOP was being used actively in practice by the survey respondents ranged from a low of 22.7% (for the "Fatigue" SOP) to a highest of 48.5% (for the "Palliative Sedation" and "Respiratory Distress" SOPs). The respondents became aware of the SOP through recommendations from colleagues, team meetings or from the head of the department. The SOPs "Respiratory distress of an adult palliative patient" and "Palliative sedation" were perceived as the most practically oriented and understandable. Barriers to use SOPs were mainly limited time resources and lack of knowledge of existence and availability. CONCLUSIONS: In practice, better knowledge about the SOPs and at the same time increased use can be achieved through systematic training or discussion of SOPs in regular team meetings. There is a need to take measures to optimize the implementation in clinical practice.

Measuring the Psychosocial Dimensions of Quality of Life in Patients With Advanced Cancer: Psychometrics of the German Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire.

CONTEXT: Quality of life (QoL) is a central focus of care in advanced cancer. Specialized instruments, such as the Quality of Life at the End of Life-Cancer (QUAL-EC), may be useful to assess psychosocial issues associated with QoL unique to this population. OBJECTIVES: To evaluate the measurement of the psychosocial dimensions of QoL using the German translation of the QUAL-EC-Psychosocial (QUAL-EC-P) questionnaire, including factor structure and psychometrics. METHODS: About 183 patients with advanced cancer from the University Medical Center Hamburg-Eppendorf and University Medical Center Leipzig completed the QUAL-EC-P questionnaire. We conducted exploratory factor analysis as well as item and reliability analysis. We examined convergent validity with correlations between the scale and relevant psychological constructs. RESULTS: The sample was 60% female with mean age of 57.7 (SD = 11.7). We extracted three factors accounting for 44% of the variance aligning with the structure of the instrument. The QUAL-EC-P questionnaire showed good to acceptable internal consistency for the QoL-psychosocial total score (α = 0.77), the Life completion subscale (α = 0.77), and the Relationship with health care provider subscale (α = 0.81). The Preparation for end of life subscale had adequate albeit low internal consistency (α = 0.64) because concerns about family were less associated with financial worry and fear of death than expected. The psychosocial dimensions of QoL correlated negatively with depression (r = -0.27, P ≤ 0.001), anxiety (r = -0.32, P ≤ 0.001), demoralization (r = -0.63, P ≤ 0.001), and attachment insecurity (r = -0.51, P ≤ 0.001) and positively with spiritual well-being (r = 0.63, P ≤ 0.001). CONCLUSION: The QUAL-EC-P questionnaire may be used to assess the psychosocial aspects of QoL and promote their clinical discussion in patients with advanced cancer.

Attachment Insecurity in Advanced Cancer Patients: Psychometric Properties of the German Version of the Brief Experiences in Close Relationships Scale (ECR-M16-G).

CONTEXT: Attachment insecurity refers to difficulty in trusting and relying on others in times of need. Its underlying factors attachment anxiety and attachment avoidance have been empirically associated with impaired coping in advanced cancer and, therefore, should be considered in individually tailored medical and psychosocial treatment. OBJECTIVES: The objective of this study was to evaluate the psychometric properties of the German translation of the Brief Experiences in Close Relationships Scale (ECR-M16-G). METHODS: We recruited 182 advanced cancer patients from outpatient psycho-oncology clinics of the University Medical Center Hamburg-Eppendorf and the University Medical Center Leipzig, local and external cancer care facilities. We performed confirmatory factor analysis to replicate the higher order factor structure reported in previous research. We conducted item and reliability analysis, also correlation analysis, to examine concurrent validity. RESULTS: One hundred fifty-eight patients completed the ECR-M16-G (women 61%, mean age 57.9, SD = 11.1). We replicated the factor structure with the subscales Attachment Anxiety and Attachment Avoidance as second-order factors and Worrying about relationships, Frustration about unavailability, Discomfort with close others, and Turning away from others as first-order factors. An adjusted model that interchanged factor loadings of items 4 and 10 showed good fit (Comparative Fit Index = 0.94, Non-Normed Fit Index = 0.93, root mean square error of approximation = 0.05). Subscales showed acceptable to good internal consistency (anxiety α = .81 and avoidance α = .78). Attachment insecurity (mean = 3.1, SD = 1.0) was positively associated with depression, anxiety, demoralization (P < 0.001), and symptom burden (P = 0.02) and negatively associated with spiritual well-being (P < 0.001). CONCLUSION: The ECR-M16-G is a valid and reliable measure of attachment insecurity in patients with advanced cancer and can be recommended as a tool for clinical care and further research.

Favored subjects and psychosocial needs in music therapy in terminally ill cancer patients: a content analysis.

BACKGROUND: Research has shown positive effects of music therapy on the physical and mental well-being of terminally ill patients. This study aimed to identify favored subjects and psychosocial needs of terminally ill cancer patients during music therapy and associated factors. METHODS: Forty-one Patients receiving specialized inpatient palliative care prospectively performed a music therapy intervention consisting of at least two sessions (total number of sessions: 166; per patient average: 4, range, 2-10). Applied music therapy methods and content were not pre-determined. Therapeutic subjects and psychosocial needs addressed in music therapy sessions were identified from prospective semi-structured "field notes" using qualitative content analysis. Patient- and treatment-related characteristics as well as factors related to music and music therapy were assessed by questionnaire or retrieved from medical records. RESULTS: Seven main categories of subjects were identified: "condition, treatment, further care", "coping with palliative situation", "emotions and feelings", "music and music therapy", "biography", "social environment", and "death, dying, and spiritual topics". Patients addressed an average of 4.7 different subjects (range, 1-7). Some subjects were associated with gender (p = .022) and prior impact of music in patients' life (p = .012). The number of subjects per session was lower when receptive music therapy methods were used (p = .040). Psychosocial needs were categorized into nine main dimensions: "relaxing and finding comfort", "communication and dialogue", "coping and activation of internal resources", "activity and vitality", "finding expression", "sense of self and reflection", "finding emotional response", "defocusing and diversion", and "structure and hold". Patients expressed an average of 4.9 psychosocial needs (range, 1-8). Needs were associated with age, parallel art therapy (p = .010), role of music in patient's life (p = .021), and the applied music therapy method (p = .012). CONCLUSION: Seven main categories of therapeutically relevant subjects and nine dimensions of psychosocial needs could be identified when music therapy was delivered to terminally ill cancer patients. Results showed that patients with complex psychosocial situations addressed an average number of five subjects and needs, respectively. Some socio-demographic factors, the role of music in patient's lives and the applied music therapy methods may be related with the kind and number of expressed subjects and needs.

Prospective Study on Music Therapy in Terminally Ill Cancer Patients during Specialized Inpatient Palliative Care.

OBJECTIVE: This study was a prospective evaluation of feasibility, acceptance, and potential beneficial effects of music therapy in terminally ill cancer patients on a specialized palliative care inpatient ward. METHODS: Intervention had to consist of at least two sessions, but frequency and duration was left to the patients` decision. Different music therapy methods were offered to the patient at the beginning of every session. Patients rated their subjective benefit. Disease-related and sociodemographic factors were considered as potentially influencing factors. RESULTS: A total of 166 music therapy sessions were performed with 41 patients (average, 4; range, 2-10). Average session duration was 41 minutes (range, 20-70). Most favored methods were therapeutic conversation in 84% of sessions; listening to relaxing music, 39%; playing an instrument, 31%; and music-lead imagination, 11%. Receptive music therapy was applied in 45%, active forms in 25%, a combination of both in 7%, and therapeutic conversation only in 23%. Music therapy was rated to be "helpful" in 68%. Positive effects were significantly associated with frequency (p = 0.009) and duration (p = 0.040), living in a partnership (p = 0.017), having children (p = 0.035), psycho-oncologic therapy (p = 0.043), experience with music therapy (p = 0.007), role of music in life (p = 0.035), playing an instrument (p = 0.021), and singing regularly (p = 0.003). CONCLUSION: Music therapy techniques, especially receptive methods, are feasible and well accepted in terminally ill cancer patients. Therapeutic conversation seems to play an important role. Frequency and duration of music therapy, previous experience with music and music therapy, as well as sociodemographic factors influence positive effects of music therapy.

Relationship between symptom burden, distress, and sense of dignity in terminally ill cancer patients.

CONTEXT: Maintaining a sense of dignity in terminally ill patients and enabling a dignified dying are important aims of palliative care. OBJECTIVES: To evaluate the impact of symptom burden, distress, overall condition, and individual patient characteristics on self-perceived dignity in terminally ill cancer patients. METHODS: In this cross-sectional study, 61 patients were recruited through a palliative care inpatient ward within 48 hours after admission. Patients completed the Patient Dignity Inventory, a modified version of the Memorial Symptom Assessment Scale, the National Comprehensive Cancer Network Distress Thermometer, and a single-item scale rating subjective of overall condition. Sociodemographic parameters and performance status were taken from the patients' records. RESULTS: Dignity total score correlated highest with lack of energy (P<0.001), anxiety (P<0.001), sadness (P=0.002), pain (P=0.009), shortness of breath (P=0.019), irritability (P=0.023), thirst (P=0.029), and tiredness (P=0.041). Psychological symptoms showed more consistent associations with the different dignity dimensions than physical symptoms except for the dependency dimension. Psychological distress correlated with all dignity dimensions: symptom distress (P<0.001), existential distress (P<0.001), dependency (P=0.020), peace of mind (P<0.001), and social support (P=0.024). Overall condition was significantly associated with existential distress (P=0.013), but not with symptom distress, dependency, peace of mind, or social support. Performance status showed significant association with dependency (P=0.001). CONCLUSION: Self-perceived dignity in terminally ill cancer patients is significantly associated with physical as well as psychological symptoms, distress, overall condition, performance status, and comorbidities. Knowledge of these specific interactions is essential for adequate, comprehensive palliative care.

Anxiety and depression in caregivers of terminally ill cancer patients: impact on their perspective of the patients' symptom burden.

BACKGROUND AND OBJECTIVE: Given the important role caregivers play in palliative care planning and decision making, anxiety and depression in caregivers of terminally ill cancer patients and their impact on the caregivers' evaluation of the patients' physical and psychological symptom burden were analyzed. DESIGN AND SUBJECTS: Thirty-three patients and their caregivers were recruited through the University Medical Center palliative care inpatient ward <24 h after admission. MEASUREMENTS: Patients completed the Memorial Symptom Assessment Scale (MSAS). Caregivers were instructed to evaluate the symptom burden of the patient. Anxiety and depression were measured in caregivers using the PHQ-9 and the GAD-7. RESULTS: Fifty-five percent of male caregivers and 36% of female caregivers showed moderate or severe anxiety; 36% of male caregivers compared to 14% of female caregivers had moderate or severe depression. Caregivers' anxiety was associated with a discrepancy in the patients' symptom evaluation for shortness of breath (p<0.05); nausea (p<0.05); and frequency, intensity, and distress due to anxiety (p<0.01). Depression was associated with a discrepancy in the patients' evaluation of distress due to constipation (p<0.05), as well as intensity and distress due to anxiety (p<0.05). Both the caregivers' anxiety and depression were not significantly associated with an underestimation of symptoms. There was a trend towards a higher risk of overestimation in caregivers with higher levels of anxiety (r=0.32) (p=0.07) and depression (r=0.33) (p=0.06). CONCLUSION: Integrative palliative care should offer psychooncological care for the caregivers on a routine basis to avoid misleading perspectives possibly influencing end-of-life treatment decisions.

Patterns of relapse after chemotherapy in patients with high-risk non-seminomatous germ cell tumor.

OBJECTIVES: We investigated the pattern of relapse after chemotherapy in patients with high-risk germ cell tumor (GCT) to critically review common follow-up procedures including close monitoring of serum tumor markers and radiologic procedures. METHODS: 645 patients received first-line (434 patients) or salvage platinum-based (211 patients) high-dose chemotherapy in three multicenter trials. Retrospective analysis comprised 77 patients after first-line and 61 after salvage chemotherapy, who had achieved at least a partial remission but progressed afterwards. RESULTS: At relapse, 24% of the patients presented with an isolated elevation in serum tumor markers, 26% with pathologic radiologic confirmation with negative tumor markers, and 42% with elevated tumor markers and radiologically confirmed progression. Relapse was detected by clinical symptoms in 8%. 46% relapsed within 3 months and 97% within 2 years. Relapse pattern did not correlate with tumor marker status or metastasis location prior to chemotherapy, line of chemotherapy, response status after chemotherapy or time point of relapse. CONCLUSION: In high-risk GCT patients, relapse after chemotherapy is detected either by tumor marker elevation alone, radiologic imaging alone or both, in one third each. Close monitoring including serum tumor markers, radiologic imaging and clinical examination appears warranted within the first 2 years.

Four consecutive multicenter phase II trials of adjuvant chemoradiation in patients with completely resected high-risk gastric cancer: the experience of the German AIO/ARO/CAO group.

PURPOSE: Feasibility and efficacy of four different adjuvant radiochemotherapy regimens in patients with completely resected gastric cancer were evaluated in consecutive cooperative phase II trials using different 5-fluorouracil (5-FU)-based combination chemotherapies (CTX) and 5-FU-enhanced radiotherapy. METHODS: Between 2000 and 2005, 157 patients with completely resected gastric adenocarcinoma were included. The study design was based on two cycles of CTX and irradiation with 45 Gy plus concomitant 5-FU 225 mg/m(2) per 24 h between these two cycles. CTX cycles consisted of 5-FU, folinic acid (FA), cisplatin plus paclitaxel (FLPP); 5-FU, FA and cisplatin (FLP); 5-FU, FA and irinotecan (FLI); or 5-FU, cisplatin plus docetaxel (FPD). RESULTS: Median follow-up for all four trials was 18 months (range, 1-64) without significant difference between the four regimens: FLPP 30 months (2-46+), FLP 18 months (1-64+), FLI 15 months (1-26), FPD 10 months (5-19+). Treatment associated toxicity was tolerable and did not differ significantly between the four CTX regimens. Across all patients grade (3/4), toxicities during the first cycle/chemoradiation/second cycle consisted of leukocytopenia 4%/2%/30%, anorexia 5%/10%/6%, diarrhea 6%/1%/3%, nausea 2%/7%/2%. Early death occurred in one patient due to Pneumocystis carinii pneumonia. Median progression free survival was 23 months for FLPP, 18 months for FLP, 14 months for FLI, 9 months for FPD (not significant). One-year-overall survival rates were 95% for FLPP, 82% for FLP, 94% for FLI, 86% for FPD. CONCLUSION: Adjuvant radiochemotherapy in patients with gastric cancer can be safely given continuous infusion of 5-FU at 225 mg/m(2) per day. In addition, a variety of 5-FU-based multiagent chemotherapy regimen with defined activity in gastric cancer appears both safe and effective when given prior and after radiochemotherapy in this setting.

An open-label, multicenter phase II trial of capecitabine in patients with cisplatin-refractory or relapsed germ cell tumors.

The objective of this multicenter phase II trial was to evaluate the efficacy and tolerability of capecitabine in patients with cisplatin-refractory or relapsed germ cell tumors. Between March 2003-June 2004, 14 patients refractory to at least two regimens of cisplatin-based chemotherapy or with relapse after high-dose chemotherapy and autologous peripheral blood stem cell transplantation received 1250 mg/qm capecitabine orally twice daily for 14 days in 3-week cycles. Treatment was continued until tumor progression. All patients were heavily pretreated with a median number of four previous lines of chemotherapy (range, 2-11) and 86% had relapsed after high-dose chemotherapy with peripheral blood stem cell transplantation. No patient responded to study treatment. Nine patients (64%) had progressive disease after two cycles. Two patients already stopped treatment after one cycle, because of a clinically overt tumor progression. One patient died of his tumor progression at the end of the second cycle. Two patients received four cycles of capecitabine, as progression was less than 30%. The median survival time was 4 months (range, 0-10). The toxicity profile was favorable. Eighty-six percent of the cycles could be applied without dose modifications or delay. Grade III/IV toxicities (diarrhea and anorexia in one patient each) occurred in 7% of the cases. No hematotoxicity grade III/IV was observed. Neutropenia grade I/II was documented in 21%, anemia in 35% and thrombocytopenia in 14% of the patients. Capecitabine was well tolerated, but is not effective in heavily pretreated patients with cisplatin-refractory or relapsed germ cell tumors.